{
  "schema_version": "chamgap-public-evidence-check-1.0",
  "public_id": "v3106-main",
  "verdict_number": "3106",
  "title": "Biotin × Falsely low TSH measurement bias",
  "view_version": "1.0",
  "view_created_date": "2026-11-03",
  "criteria_version": "NGM-v3106-ORAL-BIOTIN-TSH-MEASUREMENT-1.0",
  "criteria_date": "2026-10-05",
  "review_date": "2026-10-05",
  "legacy_evidence_date": "2026-09-15",
  "review_scope": {
    "materials_read": "Stored Korean and English manuscripts, bibliography and structure, 40 conditions, and application and review records",
    "clinical_papers_directly_read": false,
    "new_clinical_search": false,
    "limitation": "External clinical papers, supplements, registrations, analysis plans and full texts of new methodological sources were not read in this review. Historical access records are distinguished from the current reading of stored summaries; no new search, calculation or reassessment was conducted.",
    "date_meaning": "This is the date the stored materials were checked, not the date of an up-to-date clinical literature search.",
    "current_retained_material_read_date": "2026-11-03"
  },
  "claim_context": {
    "population": "Detailed direct evidence concerns healthy adults; no automatic extension to patients, renal impairment or pregnancy",
    "intervention": "Biotin · Study-specific biotin supplements; tablet/capsule, exact composition and batch unverified · Oral",
    "dose": "5 mg/day or 10 mg/day; separated by study, platform and blood sampling time",
    "comparator": "The same participants before exposure and after washout, and comparator platforms on specimens from the same time point; not presented as a randomized placebo trial",
    "endpoint": "TSH assay bias relative to pre-exposure/post-washout measurements or a biotin-independent method; clinical reference-limit crossing considered separately",
    "duration": "7 or 8 days of exposure; dosing duration and the interval from the last dose to blood sampling kept separate",
    "excluded_extensions": "Thyroid function/treatment effects, diagnostic accuracy/actual misdiagnosis/patient harm rates, all analytes/reagents, a universal stopping interval, and extensions to safe human doses/special populations are separate questions."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Measurement-only display",
      "question": "Does this table address a measurement question and prevent the application of efficacy grades and scores?",
      "needed": "Measurement-only classification, fields marking efficacy as not applicable, and a display contract prohibiting efficacy badges/aggregate ratings/a universal stopping interval",
      "role": "Required",
      "role_reason": "This is needed to prevent falsely low measurements from being recast as treatment effects or an aggregate grade.",
      "application_exception": "The original grade ?·score null and document quality B are historical values. Blue in the condition status indicates verification of a narrow documentation condition, not an efficacy badge.",
      "criterion": "Preserve measurement_only, the measurement type, the non-applicability of efficacy grade/score/axes, and the original display_contract unchanged.",
      "basis": "C01: Question clarification principles in M03 §3.1, §3.2.1–3.2.4; the detailed separation rules are internally designed / C09: M04 §4.5, §4.6.3; limits on the current data transformation follow the user-defined scope and are internally designed / D01: Chamgap's own diagnostic condition; M03 question/population principles serve only as general references. Reason for application to the measurement family: This is needed to prevent falsely low measurements from being recast as treatment effects or an aggregate grade. This is not a formal implementation of diagnostic/QUADAS/STARD·RoB/GRADE/causality methods or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Cross-check the display paths for measurements, reagent performance, document quality and patient outcomes separately to prevent conflated labeling.",
      "current_reports": [],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "The original data have measurement_only=true, question_type=measurement. Efficacy grade·score·axes are not_applicable, and efficacy badges, aggregate ratings and a universal stopping interval are prohibited. The original grade ?·score null are not used as a new efficacy assessment.",
      "condition_status": "Met",
      "status_reason": "This documentation condition links the original measurement classification and display prohibitions unchanged. It does not mean certification of clinical efficacy or absence of interference.",
      "missingness": "No new efficacy grade or aggregate measurement score is created.",
      "uncertainty": "No new efficacy grade or aggregate measurement score is created. This status reflects the documented scope of the specific narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/personal safety, the actual misdiagnosis rate, or absence of evidence worldwide.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Measurement-only classification, fields marking efficacy as not applicable, and a display contract prohibiting efficacy badges/aggregate ratings/a universal stopping interval"
    },
    {
      "item_id": "N02",
      "question_type": "Separate question and family",
      "question": "Which exposure, specimen, comparison and measurement outcome are brought together in one table?",
      "needed": "The original claim and a fixed question specified by healthy adults, oral exposure, serum TSH, platform/reagent, dose and blood sampling time",
      "role": "Required",
      "role_reason": "This is needed to avoid conflating thyroid disease, other analytes and all test interference with this TSH measurement bias.",
      "application_exception": "Even when some concepts from the diagnostic accuracy family are used as references, the question is not changed into one about sensitivity/specificity or a clinical treatment trial.",
      "criterion": "Fix the oral exposure, serum TSH, assay-specific falsely low readings and actual within-person/same-specimen comparisons, and distinguish questions that extend beyond them.",
      "basis": "C01: Question clarification principles in M03 §3.1, §3.2.1–3.2.4; the detailed separation rules are internally designed / C04: M03 §3.2.1; detailed population conditions are internally designed / C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed / D01: Chamgap's own diagnostic condition; M03 question/population principles serve only as general references / D09: Chamgap's own boundary for diagnostic extensions; formal diagnostic methodology evidence has not been reviewed / E09: M03 §3.2.4; internally designed boundary for extensions. Reason for application to the measurement family: This is needed to avoid conflating thyroid disease, other analytes and all test interference with this TSH measurement bias. This is not a formal implementation of diagnostic/QUADAS/STARD·RoB/GRADE/causality methods or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Construct a matrix of platform, reagent, exposure and time point, and cross-check measurement bias separately from physiological changes/clinical outcomes.",
      "current_reports": [
        "S01",
        "S04",
        "S05",
        "S08"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "The single claim concerns falsely low readings in specific serum TSH assays after oral biotin. The actual comparisons are within the same people before exposure and after washout, or between platforms using specimens from the same time point; they do not concern biotin's thyroid treatment effect or actual misdiagnosis rates.",
      "condition_status": "Met",
      "status_reason": "The original claim and the boundaries of the measurement family were verified. Results from some assays were not extended to all TSH assays or clinical diseases.",
      "missingness": "Other analytes, actual changes in thyroid function, misdiagnosis/patient harm and a universal stopping interval are separate questions.",
      "uncertainty": "Other analytes, actual changes in thyroid function, misdiagnosis/patient harm and a universal stopping interval are separate questions. This status reflects the documented scope of the specific narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/personal safety, the actual misdiagnosis rate, or absence of evidence worldwide.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "The original claim and a fixed question specified by healthy adults, oral exposure, serum TSH, platform/reagent, dose and blood sampling time"
    },
    {
      "item_id": "N03",
      "question_type": "Analyte and units",
      "question": "Which TSH measure in which specimen does the observed outcome represent?",
      "needed": "Serum TSH analyte, units, time-point/contrast definitions, and separate blood biotin units",
      "role": "Required",
      "role_reason": "This is needed to avoid substituting blood biotin concentrations, TSH measurements or disease status for one another.",
      "application_exception": "Keep blood biotin in pg/mL and reagent-document values in ng/mL, and TSH in mIU/L and document values in µIU/mL, each in its original units. No new conversions are performed.",
      "criterion": "Assign assay-specific serum TSH time-point means, formal contrasts and reference-limit crossings to their respective original units/time points.",
      "basis": "C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed / D03: Chamgap's own diagnostic condition; formal diagnostic methodology evidence has not been reviewed. Reason for application to the measurement family: This is needed to avoid substituting blood biotin concentrations, TSH measurements or disease status for one another. This is not a formal implementation of diagnostic/QUADAS/STARD·RoB/GRADE/causality methods or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Cross-check analytes, units and measures against each original table/document without generating new converted values or clinical status classifications.",
      "current_reports": [
        "S01",
        "S03",
        "S08"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "The selected outcome is the serum TSH assay value. Li's TSH is in mIU/L and the Roche document's criteria are in µIU/mL; these are distinguished from blood biotin in pg/mL and document values in ng/mL. The original units were not converted and combined.",
      "condition_status": "Met",
      "status_reason": "The condition distinguishing the retained original units and analytes was verified. Physiological thyroid status was not determined.",
      "missingness": "Conversions between original documents or application of patient diagnostic thresholds are not performed in this review.",
      "uncertainty": "Conversions between original documents or application of patient diagnostic thresholds are not performed in this review. This status reflects the documented scope of the specific narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/personal safety, the actual misdiagnosis rate, or absence of evidence worldwide.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Serum TSH analyte, units, time-point/contrast definitions, and separate blood biotin units"
    },
    {
      "item_id": "N04",
      "question_type": "Exposure product and chemical form",
      "question": "Are the actual form, batch and total exposure to the biotin supplement known?",
      "needed": "Exact chemical form, formulation, batch, purity and dosing records for the study product, and total dietary exposure data",
      "role": "Required",
      "role_reason": "This is needed to avoid extending the name biotin and the nominal dose to the composition, purity and actual intake of all supplements.",
      "application_exception": "Unverified manufacturing source, chemical form, tablet/capsule, batch and dietary exposure do not constitute a finding that a particular product is defective.",
      "criterion": "Distinguish each study's supplement exposure from unverified product/dietary details.",
      "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed / H05: Design considerations in M19 §19.2.2–19.2.4; detailed confounding records are internally designed. Reason for application to the measurement family: This is needed to avoid extending the name biotin and the nominal dose to the composition, purity and actual intake of all supplements. This is not a formal implementation of diagnostic/QUADAS/STARD·RoB/GRADE/causality methods or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Link study product specifications and actual intake records to measurements by platform/time point to compare differences between products.",
      "current_reports": [
        "S01",
        "S04",
        "S05"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "Oral biotin supplement exposure is retained in the record, but the manufacturing source, exact chemical form, tablet/capsule, composition, batch, purity and total dietary exposure remain unverified.",
      "condition_status": "Unverified",
      "status_reason": "The currently retained information does not identify product details or total actual exposure. The nominal dose was not used to fill these gaps.",
      "missingness": "Product specifications, adherence/intake records and dietary exposure for each trial.",
      "uncertainty": "Product specifications, adherence/intake records and dietary exposure for each trial. This status reflects the documented scope of the specific narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/personal safety, the actual misdiagnosis rate, or absence of evidence worldwide.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Exact chemical form, formulation, batch, purity and dosing records for the study product, and total dietary exposure data"
    },
    {
      "item_id": "N05",
      "question_type": "Oral dose and timeline",
      "question": "Were dosing duration and the interval from the last dose to blood sampling distinguished?",
      "needed": "Nominal oral dose, dosing start/end, actual last dose and blood sampling times for each trial",
      "role": "Required",
      "role_reason": "This is needed to avoid treating 7-day/8-day exposure and blood sampling after 2 hours/5 hours/8 hours as the same timeline.",
      "application_exception": "The tested 5/10 mg doses are not interpreted as safe doses, optimal doses or personal dosing/stopping instructions.",
      "criterion": "Retain the oral dose, dosing duration, assessment day and post-dose blood sampling time for Li, Zhang and Ylli separately by study.",
      "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed / H02: Design-specific harm questions in M19 §19.2; details of temporal relationships are internally designed / E08: M03 §3.2.1–3.2.4; details of dose, duration and effect modification are internally designed. Reason for application to the measurement family: This is needed to avoid treating 7-day/8-day exposure and blood sampling after 2 hours/5 hours/8 hours as the same timeline. This is not a formal implementation of diagnostic/QUADAS/STARD·RoB/GRADE/causality methods or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Cross-check dose, dosing duration, last dose and blood sampling time against the original records as separate axes.",
      "current_reports": [
        "S01",
        "S04",
        "S05"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "Li used 10 mg/day for 7 days, with sampling approximately 2 hours after the last dose on day 7, and after 7 days off on day 14. Zhang used the same 10 participants at 5/10 mg/day for 7 days each; Ylli used 10 mg/day for 8 days, with measurements on day 1/day 8 before dosing and at 2 hours and 5 hours.",
      "condition_status": "Partly verified",
      "status_reason": "The reported timelines were linked, but not all records of individual actual intake/timing and total dietary exposure were verified.",
      "missingness": "Actual individual dosing times, adherence, total exposure and original blood sampling records for each trial.",
      "uncertainty": "Actual individual dosing times, adherence, total exposure and original blood sampling records for each trial. This status reflects the documented scope of the specific narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/personal safety, the actual misdiagnosis rate, or absence of evidence worldwide.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Nominal oral dose, dosing start/end, actual last dose and blood sampling times for each trial"
    },
    {
      "item_id": "N06",
      "question_type": "Population and representativeness",
      "question": "To which populations can the measurements in healthy adults be applied?",
      "needed": "Recruitment/selection, baseline thyroid/renal function, age/sex composition and special-population data for each trial",
      "role": "Required",
      "role_reason": "This is needed to avoid extending a small sample of healthy people to all patients, people with renal impairment, pregnant people, children and high-dose treatment groups.",
      "application_exception": "The description of participants as healthy adults alone does not verify recruitment representativeness, sex/age composition and exclusion criteria in full.",
      "criterion": "Distinguish each study's actually reported population from unverified selection/baseline characteristics and limitations concerning special populations.",
      "basis": "C04: M03 §3.2.1; detailed population conditions are internally designed / D02: Chamgap's own diagnostic sampling condition; formal diagnostic methodology evidence has not been reviewed / H08: M19 §19.1.2–19.2.4; internal application. Reason for application to the measurement family: This is needed to avoid extending a small sample of healthy people to all patients, people with renal impairment, pregnant people, children and high-dose treatment groups. This is not a formal implementation of diagnostic/QUADAS/STARD·RoB/GRADE/causality methods or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Cross-check population composition and baseline status against exposure/measurement conditions, and assess applicability to other populations using direct data from those populations.",
      "current_reports": [
        "S01",
        "S04",
        "S05"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "The detailed direct evidence from Li and Zhang concerns healthy adults. Ylli has an abstract-level record of 13 adults, while the detailed analysis population remains unverified. These data do not establish the magnitude/duration in patients, people with renal impairment, pregnant people, children or high-dose treatment groups.",
      "condition_status": "Partly verified",
      "status_reason": "The scope of the reported population is available, but detailed recruitment/baseline characteristics and general applicability are currently unverified.",
      "missingness": "Selection, exclusion and baseline status for each population, and direct measurement information for each special population.",
      "uncertainty": "Selection, exclusion and baseline status for each population, and direct measurement information for each special population. This status reflects the documented scope of the specific narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/personal safety, the actual misdiagnosis rate, or absence of evidence worldwide.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Recruitment/selection, baseline thyroid/renal function, age/sex composition and special-population data for each trial"
    },
    {
      "item_id": "N07",
      "question_type": "Li participants and specimens",
      "question": "What denominators do Li's 6 people and 18 time-point specimens represent?",
      "needed": "Li's participant count, time-point specimen count, and measurement/analysis and exclusion flow by platform",
      "role": "Required",
      "role_reason": "This is needed to avoid overstating sample size and precision by counting repeated specimens as independent participants.",
      "application_exception": "Verification of 18 specimens does not mean that missingness and exclusion flows were verified for every assay/time point.",
      "criterion": "Distinguish repeated measurements within the same 6 people from the 18 time-point specimens, and retain gaps in the actual analysis flow.",
      "basis": "C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed / D06: Chamgap's own diagnostic condition; formal diagnostic methodology evidence has not been reviewed. Reason for application to the measurement family: This is needed to avoid overstating sample size and precision by counting repeated specimens as independent participants. This is not a formal implementation of diagnostic/QUADAS/STARD·RoB/GRADE/causality methods or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Cross-check the correspondence among participants, specimens, platforms and time points against the original flow/tables to verify the unit of analysis.",
      "current_reports": [
        "S01"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "Li compared 6 healthy adults before exposure, on day 7 and on day 14. The 18 serum time-point specimens were not treated as 18 participants or 18 independent samples.",
      "condition_status": "Met",
      "status_reason": "The retained distinction between participant and repeated-specimen denominators was verified. This did not newly establish every detailed analysis denominator.",
      "missingness": "Detailed flow of analyzable specimens and exclusions/missingness by platform/time point.",
      "uncertainty": "Detailed flow of analyzable specimens and exclusions/missingness by platform/time point. This status reflects the documented scope of the specific narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/personal safety, the actual misdiagnosis rate, or absence of evidence worldwide.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Li's participant count, time-point specimen count, and measurement/analysis and exclusion flow by platform"
    },
    {
      "item_id": "N08",
      "question_type": "Zhang's same participants",
      "question": "Do Zhang's two doses represent trials with different groups of 10 people each?",
      "needed": "Identity of the same participants, exposure order and duration, and analysis flow by dose/platform/time point",
      "role": "Required",
      "role_reason": "This is needed to avoid counting fixed-sequence exposures in the same participants as 20 people or two independent trials.",
      "application_exception": "The results at the two doses are not recast as a randomized dose comparison or an estimate of interaction between doses.",
      "criterion": "Retain the same 10 people, the fixed sequence of 7 days each, and the unverified numbers of analyzed specimens by platform/time point.",
      "basis": "C02: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application / C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed / D06: Chamgap's own diagnostic condition; formal diagnostic methodology evidence has not been reviewed. Reason for application to the measurement family: This is needed to avoid counting fixed-sequence exposures in the same participants as 20 people or two independent trials. This is not a formal implementation of diagnostic/QUADAS/STARD·RoB/GRADE/causality methods or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Cross-check exposure order, washout intervals and period effects within the same people to verify the dependence of repeated measurements.",
      "current_reports": [
        "S04"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "In Zhang, the same 10 healthy adults used 5 mg/day and 10 mg/day for 7 days each. The exact numbers of analyzed specimens by platform and time point remain unverified.",
      "condition_status": "Partly verified",
      "status_reason": "The boundary of the same 10 people is clear, but detailed analyzed-specimen denominators remain unresolved.",
      "missingness": "Exposure order/intervals and actual numbers of analyzed specimens for each dose, platform and time point.",
      "uncertainty": "Exposure order/intervals and actual numbers of analyzed specimens for each dose, platform and time point. This status reflects the documented scope of the specific narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/personal safety, the actual misdiagnosis rate, or absence of evidence worldwide.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Identity of the same participants, exposure order and duration, and analysis flow by dose/platform/time point"
    },
    {
      "item_id": "N09",
      "question_type": "Ylli enrollment and analysis",
      "question": "Do Ylli's 13 people constitute the analysis denominator for every TSH value?",
      "needed": "Ylli's enrollment/completion/TSH analysis denominators, and specimen flow for each original quantitative table and figure",
      "role": "Required",
      "role_reason": "This is needed to avoid automatically inserting the enrollment count in the abstract as the analysis denominator for full-text tables.",
      "application_exception": "Retain the direction reported in the figure captions and abstract, without reconstructing quantitative full-text tables that could not be accessed.",
      "criterion": "Distinguish the enrollment of 13 adults and the scope of the abstract/figure captions from the unverified detailed TSH analysis denominators.",
      "basis": "C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed / D06: Chamgap's own diagnostic condition; formal diagnostic methodology evidence has not been reviewed / C03: Data collection/selection principles in M04 §4.5–4.6; the separation of access and reading and the hyperlink contract are internally designed. Reason for application to the measurement family: This is needed to avoid automatically inserting the enrollment count in the abstract as the analysis denominator for full-text tables. This is not a formal implementation of diagnostic/QUADAS/STARD·RoB/GRADE/causality methods or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Map enrollment counts and analysis populations/time points to the original tables to verify the scope of missingness and exclusions.",
      "current_reports": [
        "S05"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "Ylli is recorded as having enrolled 13 adults. Extraction is limited to the abstract and figure captions; detailed TSH analysis denominators and quantitative full-text tables remain unverified.",
      "condition_status": "Partly verified",
      "status_reason": "The enrollment count and level of material were retained, and the actual analysis n was not arbitrarily fixed at 13.",
      "missingness": "Completion and analysis counts and quantitative tables by time point/assay.",
      "uncertainty": "Completion and analysis counts and quantitative tables by time point/assay. This status reflects the documented scope of the specific narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/personal safety, the actual misdiagnosis rate, or absence of evidence worldwide.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Ylli's enrollment/completion/TSH analysis denominators, and specimen flow for each original quantitative table and figure"
    },
    {
      "item_id": "N10",
      "question_type": "Design and exposure order",
      "question": "What comparisons does the actual design provide, and what does it fail to control?",
      "needed": "Actual exposure order, concurrent changes, control of background factors, and measurement/reading conditions",
      "role": "Required",
      "role_reason": "This is needed to avoid presenting within-person exposure comparisons as randomized placebo efficacy trials.",
      "application_exception": "Direct measurement results are not removed merely because the design is nonrandomized. The existence of a clinical RCT is not an essential prerequisite for measurement bias.",
      "criterion": "Retain Li's nonrandomized repeated measurements, Zhang's fixed sequence and Ylli's prospective within-person comparison, along with limitations concerning time/concurrent changes.",
      "basis": "E01: M08 §8.1–8.2.3; internal application / E04: M08 §8.2.2, M15 §15.3.1; internal application / D05: Chamgap's own diagnostic condition; formal diagnostic methodology evidence has not been reviewed / H05: Design considerations in M19 §19.2.2–19.2.4; detailed confounding records are internally designed. Reason for application to the measurement family: This is needed to avoid presenting within-person exposure comparisons as randomized placebo efficacy trials. This is not a formal implementation of diagnostic/QUADAS/STARD·RoB/GRADE/causality methods or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Distinguish comparisons across time points within the same people from comparisons of concurrent specimens to assess the effects of order, time and background changes.",
      "current_reports": [
        "S01",
        "S04",
        "S05"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "Li is a nonrandomized comparison within the same people before exposure, after exposure and after washout, and between platforms using the same specimens. Zhang uses a fixed sequence, and Ylli uses prospective within-person exposure comparisons. These were not treated as treatment effects between randomized placebo groups.",
      "condition_status": "Partly verified",
      "status_reason": "The actual design descriptions are verified, but detailed controls for order, concurrent changes and blinding remain unverified.",
      "missingness": "Specific original records of order, background/concurrent changes and reading/measurement procedures.",
      "uncertainty": "Specific original records of order, background/concurrent changes and reading/measurement procedures. This status reflects the documented scope of the specific narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/personal safety, the actual misdiagnosis rate, or absence of evidence worldwide.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Actual exposure order, concurrent changes, control of background factors, and measurement/reading conditions"
    },
    {
      "item_id": "N11",
      "question_type": "Comparison reference",
      "question": "What comparison references do pre-exposure/post-washout measurements and other platforms provide?",
      "needed": "Definitions of time contrasts, and analytical principles and traceability/reference-method information for comparisons using the same specimens",
      "role": "Required",
      "role_reason": "This is needed to avoid confusing differences between assays with established diagnostic criteria for patients' thyroid conditions.",
      "application_exception": "Even a biotin-independent method does not automatically establish an independent physiological TSH true value or a gold standard for clinical disease.",
      "criterion": "Link within-person time contrasts and comparator platforms using specimens from the same time point separately, and explain the limitations of the reference methods.",
      "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed / D04: Chamgap's own diagnostic condition; formal diagnostic methodology evidence has not been reviewed / E04: M08 §8.2.2, M15 §15.3.1; internal application. Reason for application to the measurement family: This is needed to avoid confusing differences between assays with established diagnostic criteria for patients' thyroid conditions. This is not a formal implementation of diagnostic/QUADAS/STARD·RoB/GRADE/causality methods or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Cross-check paired time contrasts and assay differences in specimens from the same time point separately, and distinguish them from determining a clinical true value.",
      "current_reports": [
        "S01",
        "S02",
        "S04"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "The actual comparisons involve the same people before exposure and after washout, and platforms using specimens from the same time point. Comparisons with biotin-independent methods are relevant to verifying measurement interference, but are not diagnostic tests that establish a patient's thyroid status.",
      "condition_status": "Partly verified",
      "status_reason": "The content of the comparisons is linked; independent reference methods/true values and diagnostic accuracy have not been verified in these materials.",
      "missingness": "Separate information on calibration/traceability of comparator methods, independent reference methods and physiological true values.",
      "uncertainty": "Separate information on calibration/traceability of comparator methods, independent reference methods and physiological true values. This status reflects the documented scope of the specific narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/personal safety, the actual misdiagnosis rate, or absence of evidence worldwide.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Definitions of time contrasts, and analytical principles and traceability/reference-method information for comparisons using the same specimens"
    },
    {
      "item_id": "N12",
      "question_type": "Analytical principles and instruments",
      "question": "Were the principles and instrument identities of the TSH assays distinguished?",
      "needed": "Instruments, reagents, principles, specimen procedures and interference tolerance thresholds for each analyte",
      "role": "Required",
      "role_reason": "This is needed to avoid treating interference on all instruments as identical solely because methods are described as sandwich or biotin-dependent.",
      "application_exception": "Vista uses a biotin-dependent TSH assay, yet there was no significant difference at the exposure tested. A positive finding is not assigned on the basis of the principle alone.",
      "criterion": "Link the TSH results from Roche, Ortho, Siemens, Abbott and Beckman separately to the level of verification of their principles/versions.",
      "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed / D03: Chamgap's own diagnostic condition; formal diagnostic methodology evidence has not been reviewed / E03: M08 Table 8.2.a, M03 §3.2.4; internal application. Reason for application to the measurement family: This is needed to avoid treating interference on all instruments as identical solely because methods are described as sandwich or biotin-dependent. This is not a formal implementation of diagnostic/QUADAS/STARD·RoB/GRADE/causality methods or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Cross-check not only instrument names but also the TSH reagents' capture/detection methods against the results at the exposure tested.",
      "current_reports": [
        "S01",
        "S02",
        "S04"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "Distinguish Roche cobas e602, Ortho VITROS 5600, Siemens Dimension Vista 1500, Abbott ARCHITECT 2000 and Zhang's Beckman UniCel DxI 800. Also retain Vista's biotin dependence and the biotin independence of Zhang's Beckman/Abbott TSH assays with their respective results.",
      "condition_status": "Partly verified",
      "status_reason": "Differences in retained instrument identities and principles are available, but historical lots and actual reagent installations in individual laboratories have not been fully verified.",
      "missingness": "Original procedures, reagent lots/versions and installation records for each assay.",
      "uncertainty": "Original procedures, reagent lots/versions and installation records for each assay. This status reflects the documented scope of the specific narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/personal safety, the actual misdiagnosis rate, or absence of evidence worldwide.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Instruments, reagents, principles, specimen procedures and interference tolerance thresholds for each analyte"
    },
    {
      "item_id": "N13",
      "question_type": "Historical reagents and current installations",
      "question": "Are historical tests and current reagents with the same instrument name being treated as identical?",
      "needed": "Reagent lots and method versions at the time of the trial, revision histories and actual laboratory installation records",
      "role": "Required",
      "role_reason": "This is needed to avoid automatically transferring interference in historical trials to revised reagents or the versions currently installed in all laboratories.",
      "application_exception": "The existence of a Roche 2024 document does not verify actual installations in individual laboratories or equivalence to historical lots.",
      "criterion": "Separate the unverified historical reagents/lots from the known identity of the 2024-10 V2.0 document.",
      "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed / D03: Chamgap's own diagnostic condition; formal diagnostic methodology evidence has not been reviewed / D08: Chamgap's own diagnostic applicability condition; M04 principles distinguishing reports/studies serve as general references / C09: M04 §4.5, §4.6.3; limits on the current data transformation follow the user-defined scope and are internally designed. Reason for application to the measurement family: This is needed to avoid automatically transferring interference in historical trials to revised reagents or the versions currently installed in all laboratories. This is not a formal implementation of diagnostic/QUADAS/STARD·RoB/GRADE/causality methods or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Map instruments, reagents, versions and installation dates to verify identity/differences between historical trials and current documents.",
      "current_reports": [
        "S01",
        "S04",
        "S08"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "Historical reagent lots and interference tolerance thresholds remain unverified. Roche's 2024-10 V2.0 document provides a known version boundary, but does not verify reagent identity at the time of the trials or currently across all laboratories.",
      "condition_status": "Unverified",
      "status_reason": "The required identity of lots/installations cannot be established from instrument names alone.",
      "missingness": "Direct information on historical/current reagent lots, versions and laboratory installations.",
      "uncertainty": "Direct information on historical/current reagent lots, versions and laboratory installations. This status reflects the documented scope of the specific narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/personal safety, the actual misdiagnosis rate, or absence of evidence worldwide.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Reagent lots and method versions at the time of the trial, revision histories and actual laboratory installation records"
    },
    {
      "item_id": "N14",
      "question_type": "Li formal contrast",
      "question": "Which repeated-measures contrast does Li's formal estimate represent?",
      "needed": "Formal repeated-measures contrast formula and model, and original estimates/CI/P for each platform",
      "role": "Required",
      "role_reason": "This is needed to avoid confusing the simple difference obtained by subtracting the day 7 mean from the baseline mean with the formal contrast in the original model.",
      "application_exception": "The formal 95% CI is not converted to SD or SE, and no model is newly fitted without the original data.",
      "criterion": "Link the within-person repeated-measures contrast day 7 − mean(day 0, day 14) to the estimates for each platform.",
      "basis": "C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed / E04: M08 §8.2.2, M15 §15.3.1; internal application / E05: M15 §15.3.1–15.3.3; internal application. Reason for application to the measurement family: This is needed to avoid confusing the simple difference obtained by subtracting the day 7 mean from the baseline mean with the formal contrast in the original model. This is not a formal implementation of diagnostic/QUADAS/STARD·RoB/GRADE/causality methods or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Cross-check the original contrast formula and time-point means to distinguish formal model results from historical simple arithmetic values.",
      "current_reports": [
        "S01"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "Li's formal estimate is day 7 − mean(day 0, day 14). It is a repeated-measures contrast within the same participants, not a simple change from baseline or an effect between two randomized groups. The reported 95% CI is the interval from the original model.",
      "condition_status": "Met",
      "status_reason": "The formal contrast definition and attribution of the CI were verified. No new estimation or variance calculation was performed.",
      "missingness": "The original model's detailed specifications and checks of adjustment/multiplicity remain separate outstanding items.",
      "uncertainty": "The original model's detailed specifications and checks of adjustment/multiplicity remain separate outstanding items. This status reflects the documented scope of the specific narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/personal safety, the actual misdiagnosis rate, or absence of evidence worldwide.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Formal repeated-measures contrast formula and model, and original estimates/CI/P for each platform"
    },
    {
      "item_id": "N15",
      "question_type": "Li Roche values",
      "question": "Were Li Roche's formal bias and historical simple difference distinguished?",
      "needed": "Li Roche TSH time-point means, formal contrast, original CI/P and display of historical arithmetic",
      "role": "Required",
      "role_reason": "This is needed to avoid treating values from different contrast definitions as an error requiring correction or as the same estimate.",
      "application_exception": "−0.59 is the historical simple difference in the manuscript, not a new calculation in this review. It is not combined with the formal CI.",
      "criterion": "Link 1.80→1.21→2.06 and the formal −0.72/CI/P only to Roche cobas e602 and the corresponding time points.",
      "basis": "C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed / C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed / E04: M08 §8.2.2, M15 §15.3.1; internal application / E05: M15 §15.3.1–15.3.3; internal application / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed. Reason for application to the measurement family: This is needed to avoid treating values from different contrast definitions as an error requiring correction or as the same estimate. This is not a formal implementation of diagnostic/QUADAS/STARD·RoB/GRADE/causality methods or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Map platform/time-point means and the formal contrast definition to the original table to verify the roles of the different values.",
      "current_reports": [
        "S01"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "Li Roche cobas e602 TSH was 1.80→1.21→2.06 mIU/L, with a formal contrast of −0.72 mIU/L, 95% CI −1.13~−0.32, P = 0.006. −0.59 mIU/L is the historical simple before/after difference between the displayed means; it was not newly calculated.",
      "condition_status": "Met",
      "status_reason": "The retained original Roche values and the distinction between the two contrasts were verified. They were not extended to current reagents or patient treatment effects.",
      "missingness": "Detailed verification of historical lots, actual laboratory installations and the original model.",
      "uncertainty": "Detailed verification of historical lots, actual laboratory installations and the original model. This status concerns the scope of documentation for that narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, actual misdiagnosis rates or worldwide absence of evidence.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Li Roche TSH time-point means, formal contrast, original CI/P and display of historical arithmetic"
    },
    {
      "item_id": "N16",
      "question_type": "Li Ortho values",
      "question": "What is the scope of Li's VITROS values and observations relative to the lower reference limit?",
      "needed": "VITROS time-point means, formal contrast/CI/P and the method's lower reference limit",
      "role": "Required",
      "role_reason": "This is needed to avoid turning platform-specific bias magnitudes and lower-limit crossings into findings for other assays or clinical disease incidence.",
      "application_exception": "The fact that all 6 participants were below the lower limit is an observation in a small measurement sample, not a population frequency.",
      "criterion": "Preserve the means, formal contrast, CI/P and original lower reference limit for Ortho VITROS 5600.",
      "basis": "C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed / E04: M08 §8.2.2, M15 §15.3.1; internal application / E05: M15 §15.3.1–15.3.3; internal application / D03: Chamgap's internally designed diagnostic condition; formal diagnostic-method evidence not reviewed. Reason for application to the measurement family: This is needed to avoid turning platform-specific bias magnitudes and lower-limit crossings into findings for other assays or clinical disease incidence. This is not formal implementation of diagnostic/QUADAS/STARD, RoB/GRADE or causality assessments, or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Distinguish the original formal contrast from individual reference-limit crossings and attribute them to the platform's measurement results.",
      "current_reports": [
        "S01",
        "S02"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "Ortho VITROS 5600 had means of 1.64→0.10→1.89 mIU/L, a formal contrast of −1.67 mIU/L, 95% CI −2.08~−1.26, P < 0.001. After exposure, all 6 participants were below 0.15 mIU/L, and the assay's lower reference limit was 0.47 mIU/L.",
      "condition_status": "Met",
      "status_reason": "The retained platform values and lower limit were linked accurately. They were not converted into actual hyperthyroidism or a misdiagnosis rate.",
      "missingness": "Original individual values, reagent versions and separate patient-outcome data.",
      "uncertainty": "Original individual values, reagent versions and separate patient-outcome data. This status concerns the scope of documentation for that narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, actual misdiagnosis rates or worldwide absence of evidence.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "VITROS time-point means, formal contrast/CI/P and the method's lower reference limit"
    },
    {
      "item_id": "N17",
      "question_type": "Boundaries for reference limits and misdiagnosis rates",
      "question": "Was crossing the lower reference limit expressed as sensitivity, specificity or an actual misdiagnosis rate?",
      "needed": "The method's reference limit, individual measurements and actual clinical assessments/follow-up outcome data",
      "role": "Required",
      "role_reason": "This is needed to distinguish an observation of assay values crossing the lower limit from the frequency of diagnoses/harms in patients.",
      "application_exception": "A measurement-bias question does not unconditionally require disease TP/FP/FN/TN tables or clinical outcome trials.",
      "criterion": "Separate lower-limit crossings under the test conditions from clinical disease, misdiagnosis and harm rates, and diagnostic accuracy.",
      "basis": "D03: Chamgap's internally designed diagnostic condition; formal diagnostic-method evidence not reviewed / D07: Chamgap's internally designed diagnostic-outcome condition; formal diagnostic-method evidence not reviewed / D09: Chamgap's internally designed boundary for diagnostic extensions; formal diagnostic-method evidence not reviewed / H04: M19 §19.1.2–19.2.4; internal application / H09: Chamgap's internally designed interpretation boundary. References M19 principles; not implementation of a formal causality tool. Reason for application to the measurement family: This is needed to distinguish an observation of assay values crossing the lower limit from the frequency of diagnoses/harms in patients. This is not formal implementation of diagnostic/QUADAS/STARD, RoB/GRADE or causality assessments, or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Compare assay reference-limit crossings, independent clinical status and post-test actions separately; do not estimate patient rates without that connection.",
      "current_reports": [
        "S01",
        "S02",
        "S09"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "The VITROS observation that all 6 participants were below the lower limit after exposure is a measurement under these conditions. It was not converted into a population misdiagnosis rate, incidence of actual hyperthyroidism or diagnostic sensitivity/specificity.",
      "condition_status": "Met",
      "status_reason": "This condition preserves the source's stated boundary for extending measurements to clinical outcomes. It does not mean there is no patient harm.",
      "missingness": "Denominators and follow-up records for actual patient clinical assessments, actions and harms are separately needed.",
      "uncertainty": "Denominators and follow-up records for actual patient clinical assessments, actions and harms are separately needed. This status concerns the scope of documentation for that narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, actual misdiagnosis rates or worldwide absence of evidence.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "The method's reference limit, individual measurements and actual clinical assessments/follow-up outcome data"
    },
    {
      "item_id": "N18",
      "question_type": "Li Vista contrary observation",
      "question": "Was the nonsignificant result for biotin-dependent Vista also preserved?",
      "needed": "Vista's original assay principle, paired estimate, CI/P and the exposure conditions",
      "role": "Required",
      "role_reason": "This is needed to avoid deleting a negative result that appears inconsistent with the principle or converting it into an effect of 0.",
      "application_exception": "P = 0.56 does not verify equivalence or absence of bias.",
      "criterion": "Preserve the Vista formal contrast and CI/P from the same Li specimens together with its biotin-dependent principle.",
      "basis": "C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed / E05: M15 §15.3.1–15.3.3; internal application / D03: Chamgap's internally designed diagnostic condition; formal diagnostic-method evidence not reviewed. Reason for application to the measurement family: This is needed to avoid deleting a negative result that appears inconsistent with the principle or converting it into an effect of 0. This is not formal implementation of diagnostic/QUADAS/STARD, RoB/GRADE or causality assessments, or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Relate the negative observation and the range of bias still compatible with it to the original interval/exposure conditions, distinguishing them from other platforms.",
      "current_reports": [
        "S01",
        "S02"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "In the same Li specimens, Siemens Dimension Vista 1500 had −0.11 mIU/L, 95% CI −0.49~0.26, P = 0.56. Vista TSH is biotin-dependent, but there was no significant difference at this exposure. This was not interpreted as bias of 0 or equivalence.",
      "condition_status": "Met",
      "status_reason": "The difference between the original negative finding/interval and the principle was preserved as recorded.",
      "missingness": "This observation does not establish results at other doses, blood-draw times or reagent versions.",
      "uncertainty": "This observation does not establish results at other doses, blood-draw times or reagent versions. This status concerns the scope of documentation for that narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, actual misdiagnosis rates or worldwide absence of evidence.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Vista's original assay principle, paired estimate, CI/P and the exposure conditions"
    },
    {
      "item_id": "N19",
      "question_type": "Li Abbott comparator method",
      "question": "Was Li's nonsignificant Abbott estimate kept within the scope of the comparator method?",
      "needed": "Abbott's original comparator method, exposure conditions, paired estimate and CI/P",
      "role": "Required",
      "role_reason": "This is needed to avoid extending a negative observation on the comparator platform into a guarantee of no interference under all conditions.",
      "application_exception": "Do not count another assay on the same specimens as an additional human trial or independent participants.",
      "criterion": "Attribute the Abbott ARCHITECT 2000 formal contrast, interval and P to the same Li specimens.",
      "basis": "C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed / D04: Chamgap's internally designed diagnostic condition; formal diagnostic-method evidence not reviewed / E05: M15 §15.3.1–15.3.3; internal application. Reason for application to the measurement family: This is needed to avoid extending a negative observation on the comparator platform into a guarantee of no interference under all conditions. This is not formal implementation of diagnostic/QUADAS/STARD, RoB/GRADE or causality assessments, or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Verify the original results by distinguishing platform comparisons on the same specimens from time contrasts with pre-exposure/post-washout measurements.",
      "current_reports": [
        "S01",
        "S02"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "Li's Abbott ARCHITECT 2000 formal contrast was −0.06 mIU/L, 95% CI −0.44~0.31, P = 0.74. Nonsignificance was not converted into absence of bias, equivalence or absence of interference at other exposures.",
      "condition_status": "Met",
      "status_reason": "The retained Abbott values from the same specimens were linked to the comparator method's limitations.",
      "missingness": "Other versions/exposures and independent standards/traceability for the assays.",
      "uncertainty": "Other versions/exposures and independent standards/traceability for the assays. This status concerns the scope of documentation for that narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, actual misdiagnosis rates or worldwide absence of evidence.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Abbott's original comparator method, exposure conditions, paired estimate and CI/P"
    },
    {
      "item_id": "N20",
      "question_type": "Zhang Roche doses and time points",
      "question": "At which doses and blood-draw times was lower Roche TSH observed in Zhang?",
      "needed": "Zhang's original Roche mean differences, variances, CIs, denominators and reported P by time point/dose",
      "role": "Required",
      "role_reason": "This is needed to avoid turning the direction associated with a P value into a quantitative bias magnitude or a direct effect between doses.",
      "application_exception": "Exact mean differences and CIs are unverified. Do not extract new values from graphs or search summaries.",
      "criterion": "Preserve the reported P and decreases by dose/time point in the same 10 participants, leaving unverified estimates unverified.",
      "basis": "C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed / E05: M15 §15.3.1–15.3.3; internal application / E08: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed / H02: design-specific harm questions in M19 §19.2; temporal-relationship details are internally designed. Reason for application to the measurement family: This is needed to avoid turning the direction associated with a P value into a quantitative bias magnitude or a direct effect between doses. This is not formal implementation of diagnostic/QUADAS/STARD, RoB/GRADE or causality assessments, or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Attribute results versus baseline at each dose to their time point/assay, and check whether separate direct estimates exist for comparisons between doses.",
      "current_reports": [
        "S04"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "In the same 10 participants, Roche cobas e602 TSH was lower with 5 mg at 2 hours, P = 0.005, and with 10 mg at 2 hours and 8 hours, each P < 0.001. Exact mean differences and CIs are unverified.",
      "condition_status": "Partly verified",
      "status_reason": "Direction, dose/time point and P are available, but direct quantitative bias and intervals remain to be verified.",
      "missingness": "Mean differences, CIs, actual analysis n by dose/blood-draw time and direct estimates between doses.",
      "uncertainty": "Mean differences, CIs, actual analysis n by dose/blood-draw time and direct estimates between doses. This status concerns the scope of documentation for that narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, actual misdiagnosis rates or worldwide absence of evidence.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Zhang's original Roche mean differences, variances, CIs, denominators and reported P by time point/dose"
    },
    {
      "item_id": "N21",
      "question_type": "Zhang platforms with negative findings",
      "question": "Were Zhang's negative TSH observations on Beckman and Abbott preserved by analyte?",
      "needed": "Each TSH method's reagents/principle, original results by dose/time and separate tables for other analytes",
      "role": "Required",
      "role_reason": "This is needed to avoid transferring interference in other thyroid analytes on the same instrument to TSH results.",
      "application_exception": "Nonuse of biotin-streptavidin is retained information about those TSH methods, not a guarantee for all instruments/versions.",
      "criterion": "Distinguish the negative observations and principles for Beckman UniCel DxI 800 and Abbott ARCHITECT 2000 TSH.",
      "basis": "C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed / D03: Chamgap's internally designed diagnostic condition; formal diagnostic-method evidence not reviewed / D08: Chamgap's internally designed diagnostic-applicability condition; general reference to M04 principles for distinguishing reports/studies. Reason for application to the measurement family: This is needed to avoid transferring interference in other thyroid analytes on the same instrument to TSH results. This is not formal implementation of diagnostic/QUADAS/STARD, RoB/GRADE or causality assessments, or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Hold both instrument and analyte fixed and separately compare negative TSH observations with interference results for other analytes.",
      "current_reports": [
        "S04"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "No interference was observed under the tested conditions for Zhang's Beckman UniCel DxI 800 TSH and Abbott ARCHITECT 2000 TSH. These TSH methods did not use biotin-streptavidin, and interference affecting other thyroid analytes on Beckman was not transferred to TSH.",
      "condition_status": "Partly verified",
      "status_reason": "Direction/principle is available for these TSH methods, but exact mean differences, CIs and historical reagent details are unverified.",
      "missingness": "Quantitative results, CIs and reagent lots/versions for each TSH method.",
      "uncertainty": "Quantitative results, CIs and reagent lots/versions for each TSH method. This status concerns the scope of documentation for that narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, actual misdiagnosis rates or worldwide absence of evidence.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Each TSH method's reagents/principle, original results by dose/time and separate tables for other analytes"
    },
    {
      "item_id": "N22",
      "question_type": "Zhang later blood draws",
      "question": "Was nonsignificance at 26 hours and 50 hours converted into a universal stopping interval?",
      "needed": "Original results/intervals by blood-draw time, actual dosing/stopping times and duration information by assay/population",
      "role": "Required",
      "role_reason": "This is needed to avoid extending nonsignificance at tested time points into the time when interference ends for all people, doses and assays.",
      "application_exception": "Time points after exposure stops are not recommendations for individuals to stop taking the supplement. Nonsignificance is not equivalence either.",
      "criterion": "Preserve reports of nonsignificance versus baseline at 26/50 hours for both doses only within the original conditions.",
      "basis": "C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed / E08: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed / H02: design-specific harm questions in M19 §19.2; temporal-relationship details are internally designed. Reason for application to the measurement family: This is needed to avoid extending nonsignificance at tested time points into the time when interference ends for all people, doses and assays. This is not formal implementation of diagnostic/QUADAS/STARD, RoB/GRADE or causality assessments, or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Distinguish observations at blood-draw times from criteria for absence of interference, and compare actual persistence/resolution with the original intervals and criteria for those conditions.",
      "current_reports": [
        "S04",
        "S09"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "Zhang records that no significant difference versus baseline was reported at 26 hours and 50 hours for either dose. Exact mean differences and CIs are unverified, and this is not interpreted as a universal supplement-stopping interval.",
      "condition_status": "Partly verified",
      "status_reason": "Results at the recorded later time points are available, but do not establish bias of 0 or a universal recovery time.",
      "missingness": "Quantitative intervals and criteria for absence of interference at each time point, and duration data by population/assay.",
      "uncertainty": "Quantitative intervals and criteria for absence of interference at each time point, and duration data by population/assay. This status concerns the scope of documentation for that narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, actual misdiagnosis rates or worldwide absence of evidence.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Original results/intervals by blood-draw time, actual dosing/stopping times and duration information by assay/population"
    },
    {
      "item_id": "N23",
      "question_type": "Ylli abstract-level results",
      "question": "Was the direction corroborated by Ylli distinguished from unverified quantitative tables?",
      "needed": "Ylli's original full-text quantitative tables, TSH analysis n/differences/CIs by time point and the abstract's role",
      "role": "Required",
      "role_reason": "This is needed to avoid filling in the direction in the abstract/figure captions with percentages/bias magnitudes from full-text tables.",
      "application_exception": "Do not import percentages from search summaries. The existence of a PMCID does not mean the full text was read.",
      "criterion": "Record 10 mg/day, 8 days, day 1/day 8, predose/2/5 hours and the Roche direction within the scope of the abstract.",
      "basis": "C03: data collection/selection principles in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed / E05: M15 §15.3.1–15.3.3; internal application / D08: Chamgap's internally designed diagnostic-applicability condition; general reference to M04 principles for distinguishing reports/studies. Reason for application to the measurement family: This is needed to avoid filling in the direction in the abstract/figure captions with percentages/bias magnitudes from full-text tables. This is not formal implementation of diagnostic/QUADAS/STARD, RoB/GRADE or causality assessments, or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Match the abstract/figure captions to the original tables to distinguish the level of directional verification from numerical verification.",
      "current_reports": [
        "S05"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "Ylli reported 13 adults, 10 mg/day for 8 days, and measurements on day 1/day 8 before dosing, at 2 hours and at 5 hours. The abstract supports Roche changes and the greatest interference at 2 hours, but full-text quantitative bias is unverified, and percentages from searches were not imported.",
      "condition_status": "Partly verified",
      "status_reason": "The abstract's direction and timeline are available, but quantitative tables, exact analysis denominators/CIs remain to be verified.",
      "missingness": "Quantitative bias, analysis n and CIs from the original full-text tables.",
      "uncertainty": "Quantitative bias, analysis n and CIs from the original full-text tables. This status concerns the scope of documentation for that narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, actual misdiagnosis rates or worldwide absence of evidence.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Ylli's original full-text quantitative tables, TSH analysis n/differences/CIs by time point and the abstract's role"
    },
    {
      "item_id": "N24",
      "question_type": "Roche document version",
      "question": "What are the exact version, product and platforms of the Roche method document?",
      "needed": "Roche method document version, document/product identifiers, supported platforms and installation/revision data",
      "role": "Required",
      "role_reason": "This is needed to avoid using a specific version of the method document as evidence of identical performance for all historical Roche reagents.",
      "application_exception": "The currently retained document version and the versions actually installed in all laboratories are different facts.",
      "criterion": "Preserve 2024-10 V2.0, 08429324501V2.0, 08429324160 and the e411/e601/e602 scope exactly as recorded.",
      "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed / D03: Chamgap's internally designed diagnostic condition; formal diagnostic-method evidence not reviewed / D08: Chamgap's internally designed diagnostic-applicability condition; general reference to M04 principles for distinguishing reports/studies. Reason for application to the measurement family: This is needed to avoid using a specific version of the method document as evidence of identical performance for all historical Roche reagents. This is not formal implementation of diagnostic/QUADAS/STARD, RoB/GRADE or causality assessments, or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Link document identifiers to applicable platforms, and separately compare whether the versions at the time of testing/currently installed match.",
      "current_reports": [
        "S08"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "The retained document is Roche Elecsys TSH US 2024-10 V2.0, document 08429324501V2.0, product ref 08429324160. It describes that reagent's performance on cobas e411/e601/e602 and does not verify current laboratory installations.",
      "condition_status": "Met",
      "status_reason": "The retained document's identity and scope of applicability were linked. Historical/current reagent equivalence or installation was not certified.",
      "missingness": "Historical lots and current laboratory installation/revision histories.",
      "uncertainty": "Historical lots and current laboratory installation/revision histories. This status concerns the scope of documentation for that narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, actual misdiagnosis rates or worldwide absence of evidence.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Roche method document version, document/product identifiers, supported platforms and installation/revision data"
    },
    {
      "item_id": "N25",
      "question_type": "Analytical performance acceptance criteria",
      "question": "What do the document's biotin test range and allowable deviations mean?",
      "needed": "The method document's test concentrations, allowable deviations, validation conditions and revision/installation information",
      "role": "Required",
      "role_reason": "This is needed to avoid turning an analytical validation concentration into an oral safe dose or a guarantee of bias of 0.",
      "application_exception": "Do not make new conversions between document concentrations and intake amounts. Allowable deviations differ from the absolute absence of interference.",
      "criterion": "Record ≤1200 ng/mL, an allowable deviation at TSH ≤0.2 µIU/mL of ≤0.02 µIU/mL, and ≤10% at higher TSH within the document's scope.",
      "basis": "C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed / D03: Chamgap's internally designed diagnostic condition; formal diagnostic-method evidence not reviewed / E05: M15 §15.3.1–15.3.3; internal application / H09: Chamgap's internally designed interpretation boundary. References M19 principles; not implementation of a formal causality tool. Reason for application to the measurement family: This is needed to avoid turning an analytical validation concentration into an oral safe dose or a guarantee of bias of 0. This is not formal implementation of diagnostic/QUADAS/STARD, RoB/GRADE or causality assessments, or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Compare the document's concentrations, TSH ranges and allowable deviations, and keep human oral-exposure/clinical-safety questions separate.",
      "current_reports": [
        "S08"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "The Roche document specifies a test range of biotin ≤1200 ng/mL. At TSH ≤0.2 µIU/mL, the allowable deviation is ≤0.02 µIU/mL; above that, it is ≤10%. This is an analytical performance document, not an oral safe dose or a guarantee of no interference in all laboratories.",
      "condition_status": "Met",
      "status_reason": "The original analytical acceptance values were accurately linked to their nonclinical scope.",
      "missingness": "Direct comparison of actual laboratory installations/exposure conditions with human applicability.",
      "uncertainty": "Direct comparison of actual laboratory installations/exposure conditions with human applicability. This status concerns the scope of documentation for that narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, actual misdiagnosis rates or worldwide absence of evidence.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "The method document's test concentrations, allowable deviations, validation conditions and revision/installation information"
    },
    {
      "item_id": "N26",
      "question_type": "Published correction and units",
      "question": "Was Li's published unit correction applied to the original units?",
      "needed": "Identity and original wording of the published correction, units before/after correction and locations where it applies",
      "role": "Required",
      "role_reason": "This is needed to avoid repeating the serum-biotin unit error in citations or also changing TSH units.",
      "application_exception": "Preserve the correction's original bibliographic information, including PMID/DOI. This is not a new external correction check or numerical conversion in this review.",
      "criterion": "Under the 2017-11-21 correction, distinguish biotin in pg/mL from TSH in mIU/L, which was unchanged.",
      "basis": "C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed / C09: M04 §4.5, §4.6.3; limitations on the current data transformation follow the user's scope and internal design / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed. Reason for application to the measurement family: This is needed to avoid repeating the serum-biotin unit error in citations or also changing TSH units. This is not formal implementation of diagnostic/QUADAS/STARD, RoB/GRADE or causality assessments, or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Compare the correction with its linked numbers/units, and do not change values/units outside its applicability.",
      "current_reports": [
        "S01",
        "S03"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "Under the 2017-11-21 correction, Li's serum-biotin unit was retained as pg/mL. TSH in mIU/L was unchanged. The S03 correction belongs to the same Li report family and is not an independent human trial.",
      "condition_status": "Met",
      "status_reason": "This is a documentation condition linking the retained unit correction to its applicability.",
      "missingness": "No new search was conducted in this review for additional corrections/retractions after the reference date.",
      "uncertainty": "No new search was conducted in this review for additional corrections/retractions after the reference date. This status concerns the scope of documentation for that narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, actual misdiagnosis rates or worldwide absence of evidence.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Identity and original wording of the published correction, units before/after correction and locations where it applies"
    },
    {
      "item_id": "N27",
      "question_type": "Assigned value above the upper limit",
      "question": "Is day 7 biotin of 3601 an actual precisely measured concentration?",
      "needed": "Serum-biotin measurement range, handling of values above the upper limit and the actual analytical assignment rule",
      "role": "Required",
      "role_reason": "This is needed to avoid using an assigned analysis value above the upper detection limit as an exact serum concentration or dose-concentration relationship.",
      "application_exception": "Do not convert 3601 and 3600 to other units or calculate new concentration/bias functions.",
      "criterion": "Preserve the original statement that all day 7 measurements exceeded 3600 and were assigned 3601.",
      "basis": "C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed / E05: M15 §15.3.1–15.3.3; internal application / C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed. Reason for application to the measurement family: This is needed to avoid using an assigned analysis value above the upper detection limit as an exact serum concentration or dose-concentration relationship. This is not formal implementation of diagnostic/QUADAS/STARD, RoB/GRADE or causality assessments, or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Compare the original detection range and assignment handling to distinguish actual observations, values above the upper limit and model inputs.",
      "current_reports": [
        "S01",
        "S03"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "The day 7 value of 3601 was assigned for analysis because all measurements exceeded 3600. It was not interpreted as an exact measured serum-biotin concentration or an individual dose-concentration relationship.",
      "condition_status": "Met",
      "status_reason": "The meaning of the retained upper-limit exceedance and assigned analysis value was verified.",
      "missingness": "Exact concentrations above the upper limit and individual concentration-bias relationships are unverified.",
      "uncertainty": "Exact concentrations above the upper limit and individual concentration-bias relationships are unverified. This status concerns the scope of documentation for that narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, actual misdiagnosis rates or worldwide absence of evidence.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Serum-biotin measurement range, handling of values above the upper limit and the actual analytical assignment rule"
    },
    {
      "item_id": "N28",
      "question_type": "Nonapplicability of other analytes",
      "question": "Are results for other thyroid analytes/nonhormone analytes applied to this TSH question?",
      "needed": "Analyte-specific result tables within the paper/instrument and the original selected-endpoint boundary",
      "role": "Boundaries for extensions",
      "role_reason": "This is needed to avoid combining interference in other analytes from the same paper or instrument into TSH bias.",
      "application_exception": "Do not delete other results or judge them invalid. This exception means they are outside the scope of this standalone table.",
      "criterion": "Limit the currently selected outcome to TSH and leave extensions to other analytes/treatment/patient outcomes as separate questions.",
      "basis": "C01: question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed / E09: M03 §3.2.4; internally designed boundary for extensions / D09: Chamgap's internally designed boundary for diagnostic extensions; formal diagnostic-method evidence not reviewed. Reason for application to the measurement family: This is needed to avoid combining interference in other analytes from the same paper or instrument into TSH bias. This is not formal implementation of diagnostic/QUADAS/STARD, RoB/GRADE or causality assessments, or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Separate results by analyte-platform-exposure-time point to prevent transferring other endpoints that share the same instrument name.",
      "current_reports": [
        "S01",
        "S04",
        "S07"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "Interference in other thyroid analytes on Beckman was not transferred to TSH. Nonhormone assay results in the title of the Li paper and the FDA troponin safety document are also not combined as direct numerical evidence of this TSH bias.",
      "condition_status": "Not applicable",
      "status_reason": "Direct assessment of other analytes is outside the selected TSH question. This status does not convert Not read into Not applicable.",
      "missingness": "Effects, harms and accuracy for other analytes must be reviewed with separate boundaries and direct data.",
      "uncertainty": "Effects, harms and accuracy for other analytes must be reviewed with separate boundaries and direct data. This status concerns the scope of documentation for that narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, actual misdiagnosis rates or worldwide absence of evidence.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Analyte-specific result tables within the paper/instrument and the original selected-endpoint boundary"
    },
    {
      "item_id": "N29",
      "question_type": "Specimen flow and missingness",
      "question": "Can measurements/analyses and missingness be linked by platform and time point?",
      "needed": "Participant→blood draw→specimen→platform measurement→analysis flow and handling of indeterminate/excluded/missing results",
      "role": "Required",
      "role_reason": "This is needed to avoid substituting enrollment/participant counts or time-point specimen counts as the actual denominator for every analysis.",
      "application_exception": "Do not present the absence of a detailed flow as 0 missing results or no exclusions.",
      "criterion": "Separate currently known participants/specimens from the unverified platform-specific analysis flow.",
      "basis": "C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed / D06: Chamgap's internally designed diagnostic condition; formal diagnostic-method evidence not reviewed / H06: M19 §19.1.2–19.2.4, M04 §4.6.3; internal application. Reason for application to the measurement family: This is needed to avoid substituting enrollment/participant counts or time-point specimen counts as the actual denominator for every analysis. This is not formal implementation of diagnostic/QUADAS/STARD, RoB/GRADE or causality assessments, or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Compare the actual measurement/analysis flow by platform and time point, and do not arbitrarily fill missing results with normal/0.",
      "current_reports": [
        "S01",
        "S04",
        "S05"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "Li's 6 participants and 18 time-point specimens are retained. Zhang's exact analyzed-specimen counts by platform/time point and Ylli's detailed TSH analysis denominators are unverified. The current data were not used to create claims of no missingness/exclusions or a common analysis n.",
      "condition_status": "Unverified",
      "status_reason": "Original data are insufficient to fully link the analysis flow for each platform/time point.",
      "missingness": "Original flow of successful measurements, analyses and reasons for missingness/exclusion by time point/platform.",
      "uncertainty": "Original flow of successful measurements, analyses and reasons for missingness/exclusion by time point/platform. This status concerns the scope of documentation for that narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, actual misdiagnosis rates or worldwide absence of evidence.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Participant→blood draw→specimen→platform measurement→analysis flow and handling of indeterminate/excluded/missing results"
    },
    {
      "item_id": "N30",
      "question_type": "Measurement procedures and QC",
      "question": "To what level were measurement procedures, calibration/QC and specimen handling verified?",
      "needed": "Assay-specific calibration/QC, specimen collection/storage, measurement order, reading/blinding and original methodological procedures",
      "role": "Required",
      "role_reason": "This is needed to avoid claiming that all analytical procedures and alternative explanations were verified solely from platform names and full-text reading labels.",
      "application_exception": "This is limited to the absence of detailed procedural values in the KO/structure currently read. It does not mean that the entire original full text failed to report procedures.",
      "criterion": "Distinguish the original verification locations from the information currently embedded, leaving gaps in comparison of calibration/QC, storage and measurement order/reading.",
      "basis": "D03: Chamgap's internally designed diagnostic condition; formal diagnostic-method evidence not reviewed / D05: Chamgap's internally designed diagnostic condition; formal diagnostic-method evidence not reviewed / E03: M08 Table 8.2.a, M03 §3.2.4; internal application. Reason for application to the measurement family: This is needed to avoid claiming that all analytical procedures and alternative explanations were verified solely from platform names and full-text reading labels. This is not formal implementation of diagnostic/QUADAS/STARD, RoB/GRADE or causality assessments, or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Compare handling/calibration/measurement conditions for the same specimens to verify procedures that could explain differences between time points/platforms.",
      "current_reports": [
        "S01",
        "S02",
        "S04"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "Retained S01/S02/S04 contain historical locations where methods/assay principles were verified. The KO/structure currently read does not embed detailed values for calibration/QC, storage or measurement order/reading, so those procedures were not established.",
      "condition_status": "Unverified",
      "status_reason": "The existence of a verification location differs from the detailed values embedded in the retained summary read in this review.",
      "missingness": "Actual comparison of original methodological procedures, calibration/QC, specimen handling and measurement/reading records.",
      "uncertainty": "Actual comparison of original methodological procedures, calibration/QC, specimen handling and measurement/reading records. This status concerns the scope of documentation for that narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, actual misdiagnosis rates or worldwide absence of evidence.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Assay-specific calibration/QC, specimen collection/storage, measurement order, reading/blinding and original methodological procedures"
    },
    {
      "item_id": "N31",
      "question_type": "Planning and analysis selection",
      "question": "Were registration, protocol and SAP compared with actual platforms/time points/contrasts?",
      "needed": "NCT03034707 and ChiCTR1800020472 histories, protocol/SAP, plans for platforms/endpoints/time points and numerical supplements",
      "role": "Required",
      "role_reason": "This is needed to avoid arbitrarily establishing that favorable reported platforms/time points match the original advance plan.",
      "application_exception": "Do not convert unverified registration/planning into confirmed nonregistration or selective reporting.",
      "criterion": "Link registration identifiers to original analysis locations and record that plans/multiplicity and the full numerical supplements have not been compared.",
      "basis": "E04: M08 §8.2.2, M15 §15.3.1; internal application / E06: M08 Table 8.2.a, M04 §4.6.3; internal application / C09: M04 §4.5, §4.6.3; limitations on the current data transformation follow the user's scope and internal design / D05: Chamgap's internally designed diagnostic condition; formal diagnostic-method evidence not reviewed. Reason for application to the measurement family: This is needed to avoid arbitrarily establishing that favorable reported platforms/time points match the original advance plan. This is not formal implementation of diagnostic/QUADAS/STARD, RoB/GRADE or causality assessments, or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Compare registration/plan versions and dates with the contrasts/time points actually reported, distinguishing reasons for changes and handling of multiplicity.",
      "current_reports": [
        "S01",
        "S02",
        "S04",
        "S05"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "Li's NCT03034707 and Zhang's ChiCTR1800020472 identifiers are retained. Some registration histories, protocols and SAPs, as well as numerical supplements/full tables that were not accessible in the historical record, are currently unverified. Agreement with the original plan or selective reporting was not established.",
      "condition_status": "Unverified",
      "status_reason": "Identifiers and analysis locations alone do not complete the comparison with advance plans/multiplicity.",
      "missingness": "Actual original-source comparison of registration histories, plan versions and the complete reports/supplements.",
      "uncertainty": "Actual original-source comparison of registration histories, plan versions and the complete reports/supplements. This status concerns the scope of documentation for that narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, actual misdiagnosis rates or worldwide absence of evidence.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "NCT03034707 and ChiCTR1800020472 histories, protocol/SAP, plans for platforms/endpoints/time points and numerical supplements"
    },
    {
      "item_id": "N32",
      "question_type": "Reports and study families",
      "question": "Were reports, platforms, corrections and method documents counted as independent human replications?",
      "needed": "Report-family-assay/outcome relationships and links to registrations, corrections, method documents and repeat citations",
      "role": "Required",
      "role_reason": "This is needed to avoid adding together the main article/supplement/correction from the same study, multiple platforms using the same specimens, and manufacturer documents as independent human replications.",
      "application_exception": "The direct data from F01/F02 and the abstract-level corroboration from F03 differ in evidence level. A01 is not a human study.",
      "criterion": "Link the identities and roles of F01's S01/S02/S03, F02's S04, F03's S05 and A01's S08.",
      "basis": "C02: Distinction between studies and reports in M04 §4.6.1–4.6.2; linking cohorts/outcomes is an internal application / E07: M04 §4.6.1–4.6.2, M15 §15.3.1; internal application / H07: M04 §4.6.1–4.6.2; adaptation for harm data is internally designed / D08: Chamgap's own diagnostic-application condition; general reference to M04's principle of distinguishing reports from studies. Reason for application to the measurement family: This is needed to avoid adding together the main article/supplement/correction from the same study, multiple platforms using the same specimens, and manufacturer documents as independent human replications. This is not formal implementation of diagnostic/QUADAS/STARD, RoB/GRADE or causality methods, or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Map unique participant families to report, platform and document types, and assess independence and evidence level separately.",
      "current_reports": [
        "S01",
        "S02",
        "S03",
        "S04",
        "S05",
        "S08"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "F01's Li main article S01, supplement S02 and correction S03 belong to the same family. F02's Zhang S04, F03's Ylli S05 and A01's manufacturer document S08 have distinct roles. Multiple platforms, 12 bibliographic entries and secondary citations in official documents were not counted as 12 human replications.",
      "condition_status": "Met",
      "status_reason": "The retained family identities and report roles have been linked. Replication was not calculated from the number of platforms or bibliographic entries.",
      "missingness": "Do not assume that evidence levels or population/reagent conditions are the same, or add up unverified unique participants.",
      "uncertainty": "Do not assume that evidence levels or population/reagent conditions are the same, or add up unverified unique participants. This status describes the scope of the record for the specified narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, the actual misdiagnosis rate, or a worldwide absence of data.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Report-family-assay/outcome relationships and links to registrations, corrections, method documents and repeat citations"
    },
    {
      "item_id": "N33",
      "question_type": "Funding, products and independence",
      "question": "To which report do funding, product provision and author relationships belong?",
      "needed": "Study-specific funding, product roles, author relationships, declarations in manufacturer performance documents, and their original locations",
      "role": "Required",
      "role_reason": "This is needed to avoid treating manufacturer documents or unverified funding as independent performance validation.",
      "application_exception": "Support or competing interests do not automatically invalidate a result, and a declaration of none does not establish independent verification.",
      "criterion": "Retain Li's support/relationships, Zhang's declaration of none, Ylli's unverified details and the Roche manufacturer document separately.",
      "basis": "C10: Chamgap's own independence and attribution condition. The official methods sections used in this demonstration do not warrant all of these detailed items / C02: Distinction between studies and reports in M04 §4.6.1–4.6.2; linking cohorts/outcomes is an internal application. Reason for application to the measurement family: This is needed to avoid treating manufacturer documents or unverified funding as independent performance validation. This is not formal implementation of diagnostic/QUADAS/STARD, RoB/GRADE or causality methods, or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Compare the funding/supply/declarations for the relevant report without transferring them to the independence of another study or the validity of its results.",
      "current_reports": [
        "S01",
        "S04",
        "S05",
        "S08"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "Li records NIH, university and participating-laboratory support and author-specific commercial relationships as disclosed in the original source. Zhang declares no funding/conflicts of interest; this is not independent verification. Ylli's detailed funding and product roles are unverified, and the Roche method document is a manufacturer document.",
      "condition_status": "Partly verified",
      "status_reason": "The verification levels of the reports are distinguished, but full comparison against the original detailed declarations and product roles remains outstanding.",
      "missingness": "Original detailed declarations of funding, product supply/roles and author relationships for each report.",
      "uncertainty": "Original detailed declarations of funding, product supply/roles and author relationships for each report. This status describes the scope of the record for the specified narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, the actual misdiagnosis rate, or a worldwide absence of data.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Study-specific funding, product roles, author relationships, declarations in manufacturer performance documents, and their original locations"
    },
    {
      "item_id": "N34",
      "question_type": "Current and historical reading",
      "question": "Has current reading of local summaries been distinguished from historical external access and access dates?",
      "needed": "Physical material types, URLs, historical access_level/location, report-specific access-date records and actions in this review",
      "role": "Required",
      "role_reason": "This is needed to avoid elevating publisher_full_text or other historical access_level values, or links, to original-source reading in this review.",
      "application_exception": "The original verified_date is a global review date. If a report-specific access date is absent, it remains null; historical access failures are not displayed as current failures.",
      "criterion": "Separate current reading of the retained KO/structure and bibliography from unattempted access, non-acquisition and non-reading for each external material type, and from historical access levels.",
      "basis": "C03: Data collection/selection principles in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed / C09: M04 §4.5, §4.6.3; limits on the current data transition follow the user-defined scope and internal design. Reason for application to the measurement family: This is needed to avoid elevating publisher_full_text or other historical access_level values, or links, to original-source reading in this review. This is not formal implementation of diagnostic/QUADAS/STARD, RoB/GRADE or causality methods, or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Compare each link's actual material type with its historical access level, and record dates/current access events separately.",
      "current_reports": [
        "S01",
        "S02",
        "S03",
        "S04",
        "S05",
        "S06",
        "S07",
        "S08",
        "S09",
        "S10",
        "S11",
        "S12"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "The current stored manuscript's 17 KO fields, 4 structured evidence entries and 12 bibliographic entries, plus measurement/display/correction and historical metadata, were read. Historical full text/PDF access, official extracts, abstracts and access failures are historical records. All external materials remain unread in this review; individual access dates are null, and the original review date, 2026-09-15, is separate.",
      "condition_status": "Met",
      "status_reason": "This is a record condition that separates materials actually read in the current review from historical access and dates.",
      "missingness": "The information currently available does not establish report-specific actual access dates or preservation/SHA of historical original binaries.",
      "uncertainty": "The information currently available does not establish report-specific actual access dates or preservation/SHA of historical original binaries. This status describes the scope of the record for the specified narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, the actual misdiagnosis rate, or a worldwide absence of data.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Physical material types, URLs, historical access_level/location, report-specific access-date records and actions in this review"
    },
    {
      "item_id": "N35",
      "question_type": "Candidates verified only at the metadata level",
      "question": "Were discovery leads for S10/S11/S12 elevated to direct performance figures?",
      "needed": "Original full texts/concentration-response tables and identity/access records for the S10 guideline, S11 LOCI and S12 clinical-measurement candidates",
      "role": "Required",
      "role_reason": "This is needed to avoid inventing original quantitative tables from the titles of guideline, LOCI and routine immunoassay papers whose full texts were not accessed.",
      "application_exception": "Separate unattempted access in the current review from historical full-text access failures. A link/PMCID is not evidence that the full text was read.",
      "criterion": "Retain the actual identities of the three candidates, the scope of historical discovery/failure, and the unverified original tables.",
      "basis": "C03: Data collection/selection principles in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed / C09: M04 §4.5, §4.6.3; limits on the current data transition follow the user-defined scope and internal design / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed. Reason for application to the measurement family: This is needed to avoid inventing original quantitative tables from the titles of guideline, LOCI and routine immunoassay papers whose full texts were not accessed. This is not formal implementation of diagnostic/QUADAS/STARD, RoB/GRADE or causality methods, or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Link discovered bibliographic records to full-text results without extracting or estimating concentrations/bias figures from tables that were not accessed.",
      "current_reports": [
        "S10",
        "S11",
        "S12"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "S10 ETA2026 is a historical record of metadata discovery only and a failed attempt to access the publisher's full text. The original concentration-response tables for S11 LOCI and the original extraction for S12 routine immunoassays were also unverified at that time. These were not elevated to new access or direct quantitative evidence in this review.",
      "condition_status": "Unverified",
      "status_reason": "The currently retained summaries contain no direct performance or concentration-response information.",
      "missingness": "Actual comparison against the three candidates' original full texts and tables, their currency and the reagents to which they apply.",
      "uncertainty": "Actual comparison against the three candidates' original full texts and tables, their currency and the reagents to which they apply. This status describes the scope of the record for the specified narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, the actual misdiagnosis rate, or a worldwide absence of data.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Original full texts/concentration-response tables and identity/access records for the S10 guideline, S11 LOCI and S12 clinical-measurement candidates"
    },
    {
      "item_id": "N36",
      "question_type": "Inheritance of general safety sources",
      "question": "Were the historical NIH/FDA extracts counted as independent TSH studies?",
      "needed": "Historical NIH/FDA extracts, original access histories, and the documents' actual scope of analytes/secondary citations",
      "role": "Required",
      "role_reason": "This is needed to avoid double-counting official general safety documents and secondary citations as independent human measurement results.",
      "application_exception": "Do not transfer the analyte scope of the FDA troponin document to direct TSH figures.",
      "criterion": "Retain S06/S07's inherited_official_extract status, general safety role and boundary of no new search.",
      "basis": "C02: Distinction between studies and reports in M04 §4.6.1–4.6.2; linking cohorts/outcomes is an internal application / C03: Data collection/selection principles in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed / H09: Chamgap's own interpretation boundary. Reference to M19 principles, not implementation of a formal causality tool. Reason for application to the measurement family: This is needed to avoid double-counting official general safety documents and secondary citations as independent human measurement results. This is not formal implementation of diagnostic/QUADAS/STARD, RoB/GRADE or causality methods, or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Link safety background/secondary citations in official documents to unique studies and distinguish them from independent results.",
      "current_reports": [
        "S06",
        "S07"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "NIH S06 and FDA S07 inherit the original sources, extracts and access records from earlier work, with no new search. They are general safety materials and were not counted as independent TSH studies or evidence of the same bias across all analytes.",
      "condition_status": "Met",
      "status_reason": "The distinction between official background, historical inheritance and independent replication was verified. The official documents have not been newly read in the current review.",
      "missingness": "No current comparison against the previous separate extraction/access logs and original official documents was performed.",
      "uncertainty": "No current comparison against the previous separate extraction/access logs and original official documents was performed. This status describes the scope of the record for the specified narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, the actual misdiagnosis rate, or a worldwide absence of data.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Historical NIH/FDA extracts, original access histories, and the documents' actual scope of analytes/secondary citations"
    },
    {
      "item_id": "N37",
      "question_type": "Guidance and boundaries for stopping intervals",
      "question": "Is AACC guidance distinguished from individual stopping intervals and testing/treatment schedules?",
      "needed": "The actual context of guidance recommendations by population, renal function/exposure and assay, and individual testing conditions",
      "role": "Required",
      "role_reason": "This is needed to avoid converting general guidance or study time points into a safe stopping interval for a particular person.",
      "application_exception": "The original numerical recommendations in the guidance are not embedded in the current JSON, so no new values are presented.",
      "criterion": "Link AACC's historical scope to the prohibition on a universal stopping interval or individual treatment changes.",
      "basis": "D09: Chamgap's own boundary for diagnostic extensions; official diagnostic-method evidence not reviewed / E08: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed / H02: Design-specific harm questions in M19 §19.2; timing-relationship details are internally designed / H08: M19 §19.1.2–19.2.4; internal application. Reason for application to the measurement family: This is needed to avoid converting general guidance or study time points into a safe stopping interval for a particular person. This is not formal implementation of diagnostic/QUADAS/STARD, RoB/GRADE or causality methods, or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Compare assay/population-specific guidance conditions with actual installations and exposure, without generalizing to a universal interval or individual action.",
      "current_reports": [
        "S09"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "S09 AACC2020 guidance is a historical original-source record of mechanisms, assay specificity, renal elimination and recommendations. The original table does not prescribe an individual's supplement stopping interval, testing schedule or treatment change, and prohibits a universal stopping interval.",
      "condition_status": "Partly verified",
      "status_reason": "The role of the guidance and scope of action have been linked, but the original recommendation context that is not currently embedded, and individual conditions, have not been verified.",
      "missingness": "The original recommendation context for the relevant conditions and information specific to actual exposure/installations and populations.",
      "uncertainty": "The original recommendation context for the relevant conditions and information specific to actual exposure/installations and populations. This status describes the scope of the record for the specified narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, the actual misdiagnosis rate, or a worldwide absence of data.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "The actual context of guidance recommendations by population, renal function/exposure and assay, and individual testing conditions"
    },
    {
      "item_id": "N38",
      "question_type": "Safety Warning and patient harm",
      "question": "What possibility and what actual observations does the Warning represent?",
      "needed": "Reference-limit crossing of measured values, actual clinical judgments/actions after testing, and harm definitions/collection/denominators/follow-up",
      "role": "Required",
      "role_reason": "This is needed to avoid converting the possibility of interpretation errors from falsely low measurements into an actual patient harm rate or established causation of an event.",
      "application_exception": "Do not reuse the presence of measurement bias as a judgment of individual safety/efficacy.",
      "criterion": "Retain the original safety Warning, measured values and reference-limit crossing, while distinguishing the absence of data on actual misdiagnosis/harm.",
      "basis": "H01: M19 §19.1.2–19.2.4; detailed distinctions are internally designed / H04: M19 §19.1.2–19.2.4; internal application / H09: Chamgap's own interpretation boundary. Reference to M19 principles, not implementation of a formal causality tool / D09: Chamgap's own boundary for diagnostic extensions; official diagnostic-method evidence not reviewed. Reason for application to the measurement family: This is needed to avoid converting the possibility of interpretation errors from falsely low measurements into an actual patient harm rate or established causation of an event. This is not formal implementation of diagnostic/QUADAS/STARD, RoB/GRADE or causality methods, or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Compare analytical bias separately with the timing, alternative explanations and denominators for post-test decisions and patient events to verify the scope of direct harm evidence.",
      "current_reports": [
        "S01",
        "S04",
        "S09"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "The original safety status is Warning. This reflects the possibility that falsely low TSH could lead to interpretation errors; the direct observations are assay-specific bias and reference-limit crossing. The incidence of actual patient harm is not an established result.",
      "condition_status": "Partly verified",
      "status_reason": "The original reason for the Warning and the level of direct observation have been retained. There are no data establishing the frequency/causation of actual harm.",
      "missingness": "Actual definitions and collection of patient events, denominators/follow-up, post-test actions and alternative causes.",
      "uncertainty": "Actual definitions and collection of patient events, denominators/follow-up, post-test actions and alternative causes. This status describes the scope of the record for the specified narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, the actual misdiagnosis rate, or a worldwide absence of data.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Reference-limit crossing of measured values, actual clinical judgments/actions after testing, and harm definitions/collection/denominators/follow-up"
    },
    {
      "item_id": "N39",
      "question_type": "Vulnerable populations, high doses and duration",
      "question": "Have bias magnitude and duration outside the healthy-adult conditions been verified?",
      "needed": "Actual exposure, reagents and blood-draw-time-specific bias/duration information for populations defined by renal function, pregnancy, childhood or high-dose treatment",
      "role": "Required for extension claims; supplementary to the narrow question",
      "role_reason": "This is needed to avoid extending the results of short-term exposure in healthy adults to all populations with renal impairment, pregnancy, childhood or high-dose treatment.",
      "application_exception": "Studies in every vulnerable population are not mandatory to establish this narrow measurement question, but direct information is required for the corresponding extension claims.",
      "criterion": "Record the direct study conditions separately from unverified information on special populations and long-term/rare situations.",
      "basis": "C04: M03 §3.2.1; detailed population conditions are internally designed / H08: M19 §19.1.2–19.2.4; internal application / E08: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed. Reason for application to the measurement family: This is needed to avoid extending the results of short-term exposure in healthy adults to all populations with renal impairment, pregnancy, childhood or high-dose treatment. This is not formal implementation of diagnostic/QUADAS/STARD, RoB/GRADE or causality methods, or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Compare exposure/elimination, underlying conditions and assay/time-point data for special populations, and distinguish them from healthy-adult results.",
      "current_reports": [
        "S01",
        "S04",
        "S05",
        "S09"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "These healthy-adult data did not establish bias magnitude or duration in populations with renal impairment, pregnancy, childhood or high-dose treatment. Do not generalize to individual stopping intervals or long-term safety.",
      "condition_status": "Unverified",
      "status_reason": "The currently retained materials contain no direct measurement information beyond the selected healthy-adult conditions.",
      "missingness": "Direct data on quantitative bias, intervals and duration by population, exposure and reagent.",
      "uncertainty": "Direct data on quantitative bias, intervals and duration by population, exposure and reagent. This status describes the scope of the record for the specified narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, the actual misdiagnosis rate, or a worldwide absence of data.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Actual exposure, reagents and blood-draw-time-specific bias/duration information for populations defined by renal function, pregnancy, childhood or high-dose treatment"
    },
    {
      "item_id": "N40",
      "question_type": "Reference date and update scope",
      "question": "Which retained reference date underlies the statements, and what changes trigger a new review?",
      "needed": "Reference date, current review date, search/access records, reagent revisions, original corrections/retractions, and new numerical/classification data",
      "role": "Required",
      "role_reason": "This is needed to avoid overstating the retained current value as verification of all the latest literature or current installations, or as an exhaustive search.",
      "application_exception": "Verification of new reagent documents, corrections, retractions and numerical/classification errors is not a request for automatic execution now.",
      "criterion": "Link the evidence-review date of 2026-09-15 and this review date to unverified information, corrections/revisions and the update scope.",
      "basis": "C09: M04 §4.5, §4.6.3; limits on the current data transition follow the user-defined scope and internal design / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed / C03: Data collection/selection principles in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed. Reason for application to the measurement family: This is needed to avoid overstating the retained current value as verification of all the latest literature or current installations, or as an exhaustive search. This is not formal implementation of diagnostic/QUADAS/STARD, RoB/GRADE or causality methods, or clinical certification.",
      "condition_origin": "A condition developed specifically for this case after actually reading the current measurement materials. This is an individual adaptation of the meaning of a definition, not an automatic copy, blinded assessment or clinical preregistration.",
      "proposed_research": "Retain before/after original values, versions, dates and access levels under the same ID, and compare the basis for changes and revisions of conditions as separate events.",
      "current_reports": [
        "S03",
        "S08",
        "S10"
      ],
      "existence": "Limited to the actual values in the currently retained Korean text/structure and bibliography, and the explicitly stated unverified items/historical access.",
      "acquired_read": "Summary read: The specified pointers and original values in the current stored manuscript were actually read. Access to these external material types was not attempted in this review; they were neither acquired nor read.",
      "observation": "The evidence-review date is 2026-09-15, and this retained-material transition is dated 2026-10-05. The original revision_history records the initial measurement-only current value and retains the unit correction. No new search, original-source verification or verification of reagent installations/the latest guidance was performed.",
      "condition_status": "Partly verified",
      "status_reason": "The recorded reference date and reasons for updates have been linked, but up-to-date completeness and actual current installations have not been verified.",
      "missingness": "Authorized actual comparison of reagent/publication changes, corrections, retractions and numerical/classification changes after the reference date.",
      "uncertainty": "Authorized actual comparison of reagent/publication changes, corrections, retractions and numerical/classification changes after the reference date. This status describes the scope of the record for the specified narrow measurement condition. It does not establish absence of interference, equivalence, efficacy/individual safety, the actual misdiagnosis rate, or a worldwide absence of data.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Reference date, current review date, search/access records, reagent revisions, original corrections/retractions, and new numerical/classification data"
    }
  ],
  "reports": [
    {
      "report_id": "S01",
      "title": "Li et al. 2017. Association of Biotin Ingestion With Performance of Hormone and Nonhormone Assays in Healthy Adults",
      "url": "https://jamanetwork.com/journals/jama/fullarticle/2654822",
      "report_type": "Publisher's full HTML text of the original article (historical access)",
      "existence": "The scope comprises the current 12 bibliographic entries and the actual related retained manuscript/structure. Historical non-access to full texts and historically inherited extracts are distinguished from unattempted access in this review.",
      "acquired_read": "The relevant bibliographic entry, summary and structure in the stored manuscript were read. The linked external original materials were not acquired or read in this review.",
      "study_family": "F01",
      "independent_replication": false,
      "observed_result": "Record at the time of retention: 6 healthy adults, 18 time-point specimens, 10 mg/day for 7 days. day 7 was approximately 2 hours after the last dose, and day 14 was 7 days after stopping. The formal contrast day 7 − mean(day 0, day 14) is retained separately for Roche −0.72/CI −1.13~−0.32/P = 0.006, Ortho −1.67/CI −2.08~−1.26/P < 0.001, Vista −0.11/CI −0.49~0.26/P = 0.56 and Abbott −0.06/CI −0.44~0.31/P = 0.74 mIU/L. The historical simple difference between means, −0.59, is separate from the model contrast. Serum-biotin 3601 is an assigned value after the upper limit of 3600 was exceeded. NIH, university and participating-laboratory support/author relationships are records for this study.",
      "result_level": "This is a transition of the KO/structured evidence, bibliography and historical access locations retained as of 2026-09-15. It is not external original-source reading, new numerical calculation or reassessment in this review.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "Publisher's full HTML text of the original article",
          "public_status": "Unverified (no external lookup in this review)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "The input actually read in this review is the source JSON containing the retained bibliographic entry and Korean summary/structure. No access to this external material type was attempted in this review; it was not acquired or read. This link matches the actual material type of the URL in the currently retained bibliographic entry. Historical access level: publisher_full_text. Methods; Statistical Analysis; Table 1 TSH rows; Table 4; Discussion; Article Information. Report-specific historical access dates are unverified. The stored manuscript's evidence-review date, 2026-09-15, is not the date on which the original material was actually accessed. No access to external material was attempted and no original source was read in this review.",
          "material_id": "S01-M1",
          "url": "https://jamanetwork.com/journals/jama/fullarticle/2654822",
          "bibliographic_url": "https://jamanetwork.com/journals/jama/fullarticle/2654822",
          "access_attempted": false,
          "access_succeeded": false,
          "actually_read_this_run": false
        },
        {
          "material_type": "Registration version history",
          "public_status": "Unverified (no external lookup in this review)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "The input actually read in this review is the source JSON containing the retained bibliographic entry and Korean summary/structure. No access to this external material type was attempted in this review; it was not acquired or read. A separate actual URL for this material type is currently unverified. The original bibliographic link is an identifying reference and is not presented as the original source for this material type. Historical access level: publisher_full_text. Methods; Statistical Analysis; Table 1 TSH rows; Table 4; Discussion; Article Information. Report-specific historical access dates are unverified. The stored manuscript's evidence-review date, 2026-09-15, is not the date on which the original material was actually accessed. No access to external material was attempted and no original source was read in this review.",
          "material_id": "S01-M2",
          "url": null,
          "bibliographic_url": "https://jamanetwork.com/journals/jama/fullarticle/2654822",
          "access_attempted": false,
          "access_succeeded": false,
          "actually_read_this_run": false
        },
        {
          "material_type": "Protocol",
          "public_status": "Unverified (no external lookup in this review)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "The input actually read in this review is the source JSON containing the retained bibliographic entry and Korean summary/structure. No access to this external material type was attempted in this review; it was not acquired or read. A separate actual URL for this material type is currently unverified. The original bibliographic link is an identifying reference and is not presented as the original source for this material type. Historical access level: publisher_full_text. Methods; Statistical Analysis; Table 1 TSH rows; Table 4; Discussion; Article Information. Report-specific historical access dates are unverified. The stored manuscript's evidence-review date, 2026-09-15, is not the date on which the original material was actually accessed. No access to external material was attempted and no original source was read in this review.",
          "material_id": "S01-M3",
          "url": null,
          "bibliographic_url": "https://jamanetwork.com/journals/jama/fullarticle/2654822",
          "access_attempted": false,
          "access_succeeded": false,
          "actually_read_this_run": false
        },
        {
          "material_type": "Analysis plan (SAP)",
          "public_status": "Unverified (no external lookup in this review)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "The input actually read in this review is the source JSON containing the retained bibliographic entry and Korean summary/structure. No access to this external material type was attempted in this review; it was not acquired or read. A separate actual URL for this material type is currently unverified. The original bibliographic link is an identifying reference and is not presented as the original source for this material type. Historical access level: publisher_full_text. Methods; Statistical Analysis; Table 1 TSH rows; Table 4; Discussion; Article Information. Report-specific historical access dates are unverified. The stored manuscript's evidence-review date, 2026-09-15, is not the date on which the original material was actually accessed. No access to external material was attempted and no original source was read in this review.",
          "material_id": "S01-M4",
          "url": null,
          "bibliographic_url": "https://jamanetwork.com/journals/jama/fullarticle/2654822",
          "access_attempted": false,
          "access_succeeded": false,
          "actually_read_this_run": false
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://jamanetwork.com/journals/jama/fullarticle/2654822"
        }
      ],
      "bibliographic_url": "https://jamanetwork.com/journals/jama/fullarticle/2654822",
      "historical_access_level": "publisher_full_text",
      "historical_access_location": "Methods; Statistical Analysis; Table 1 TSH rows; Table 4; Discussion; Article Information",
      "historical_access_date": null,
      "historical_source_review_date": "2026-09-15"
    },
    {
      "report_id": "S02",
      "title": "Li et al. 2017 supplementary methods and tables",
      "url": "https://cdn.jamanetwork.com/ama/content_public/journal/jama/936497/joi170104supp1_prod.pdf",
      "report_type": "Publisher's methods and numerical supplement PDF (historical access)",
      "existence": "The scope comprises the current 12 bibliographic entries and the actual related retained manuscript/structure. Historical non-access to full texts and historically inherited extracts are distinguished from unattempted access in this review.",
      "acquired_read": "The relevant bibliographic entry, summary and structure in the stored manuscript were read. The linked external original materials were not acquired or read in this review.",
      "study_family": "F01",
      "independent_replication": false,
      "observed_result": "Record at the time of retention: eFigure 1 and eTable 1, PDF p6, from the same Li study are historical locations where TSH assay principles and reference intervals were checked. These locations relate to the VITROS lower limit of 0.47 mIU/L and all 6 participants' post-exposure readings below 0.15 mIU/L, nonsignificance at this exposure despite Vista's biotin dependence, and interpretation boundaries for same-specimen comparisons. No independent participants/studies are added.",
      "result_level": "This is a transition of the KO/structured evidence, bibliography and historical access locations retained as of 2026-09-15. It is not external original-source reading, new numerical calculation or reassessment in this review.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "Methods and numerical supplement PDF",
          "public_status": "Unverified (no external lookup in this review)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "The input actually read in this review is the source JSON containing the retained bibliographic entry and Korean summary/structure. No access to this external material type was attempted in this review; it was not acquired or read. This link matches the actual material type of the URL in the currently retained bibliographic entry. Historical access level: publisher_full_pdf. eFigure 1; eTable 1, PDF p6: TSH assay principles and reference intervals. Report-specific historical access dates are unverified. The stored manuscript's evidence-review date, 2026-09-15, is not the date on which the original material was actually accessed. No access to external material was attempted and no original source was read in this review.",
          "material_id": "S02-M1",
          "url": "https://cdn.jamanetwork.com/ama/content_public/journal/jama/936497/joi170104supp1_prod.pdf",
          "bibliographic_url": "https://cdn.jamanetwork.com/ama/content_public/journal/jama/936497/joi170104supp1_prod.pdf",
          "access_attempted": false,
          "access_succeeded": false,
          "actually_read_this_run": false
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://cdn.jamanetwork.com/ama/content_public/journal/jama/936497/joi170104supp1_prod.pdf"
        }
      ],
      "bibliographic_url": "https://cdn.jamanetwork.com/ama/content_public/journal/jama/936497/joi170104supp1_prod.pdf",
      "historical_access_level": "publisher_full_pdf",
      "historical_access_location": "eFigure 1; eTable 1, PDF p6: TSH assay principles and reference intervals",
      "historical_access_date": null,
      "historical_source_review_date": "2026-09-15"
    },
    {
      "report_id": "S03",
      "title": "Incorrect Unit of Measure. JAMA 2017;318(19):1937",
      "url": "https://jamanetwork.com/journals/jama/fullarticle/2664017",
      "report_type": "Full HTML text of the published unit correction (historical access)",
      "existence": "The scope comprises the current 12 bibliographic entries and the actual related retained manuscript/structure. Historical non-access to full texts and historically inherited extracts are distinguished from unattempted access in this review.",
      "acquired_read": "The relevant bibliographic entry, summary and structure in the stored manuscript were read. The linked external original materials were not acquired or read in this review.",
      "study_family": "F01",
      "independent_replication": false,
      "observed_result": "Record at the time of retention: The published correction dated 2017-11-21 retains the serum-biotin unit as pg/mL without changing TSH mIU/L. The day 7 value of 3601 is an assignment after the upper limit of 3600 was exceeded, not an actual precisely measured concentration. The correction belongs to the same Li report family and is not a new human replication.",
      "result_level": "This is a transition of the KO/structured evidence, bibliography and historical access locations retained as of 2026-09-15. It is not external original-source reading, new numerical calculation or reassessment in this review.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "Full HTML text of the published unit correction",
          "public_status": "Unverified (no external lookup in this review)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "The input actually read in this review is the source JSON containing the retained bibliographic entry and Korean summary/structure. No access to this external material type was attempted in this review; it was not acquired or read. This link matches the actual material type of the URL in the currently retained bibliographic entry. Historical access level: publisher_full_text. Correction paragraph published 2017-11-21. Report-specific historical access dates are unverified. The stored manuscript's evidence-review date, 2026-09-15, is not the date on which the original material was actually accessed. No access to external material was attempted and no original source was read in this review.",
          "material_id": "S03-M1",
          "url": "https://jamanetwork.com/journals/jama/fullarticle/2664017",
          "bibliographic_url": "https://jamanetwork.com/journals/jama/fullarticle/2664017",
          "access_attempted": false,
          "access_succeeded": false,
          "actually_read_this_run": false
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://jamanetwork.com/journals/jama/fullarticle/2664017"
        }
      ],
      "bibliographic_url": "https://jamanetwork.com/journals/jama/fullarticle/2664017",
      "historical_access_level": "publisher_full_text",
      "historical_access_location": "Correction paragraph published 2017-11-21",
      "historical_access_date": null,
      "historical_source_review_date": "2026-09-15"
    },
    {
      "report_id": "S04",
      "title": "Zhang et al. 2020. Assessment of biotin interference in thyroid function tests",
      "url": "https://www.researchgate.net/publication/339621681_Assessment_of_biotin_interference_in_thyroid_function_tests",
      "report_type": "Full text of the original article in a repository (historical access)",
      "existence": "The scope comprises the current 12 bibliographic entries and the actual related retained manuscript/structure. Historical non-access to full texts and historically inherited extracts are distinguished from unattempted access in this review.",
      "acquired_read": "The relevant bibliographic entry, summary and structure in the stored manuscript were read. The linked external original materials were not acquired or read in this review.",
      "study_family": "F02",
      "independent_replication": false,
      "observed_result": "Record at the time of retention: The same 10 healthy adults used 5/10 mg/day for 7 days each in a fixed sequence. Roche TSH was lower at 5 mg, 2 hours, P = 0.005, and at 10 mg, 2/8 hours, each P < 0.001; at 26/50 hours, both doses had nonsignificant comparisons with baseline. Exact mean differences/CI and analyzed specimen counts by platform/time point are unverified. The specified TSH methods on Beckman UniCel DxI 800 and Abbott ARCHITECT 2000 did not use biotin-streptavidin, and interference was not observed under the tested conditions; results for other analytes are not transferred. No funding/conflicts of interest is an author declaration.",
      "result_level": "This is a transition of the KO/structured evidence, bibliography and historical access locations retained as of 2026-09-15. It is not external original-source reading, new numerical calculation or reassessment in this review.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "Full text of the original article in the ResearchGate repository",
          "public_status": "Unverified (no external lookup in this review)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "The input actually read in this review is the source JSON containing the retained bibliographic entry and Korean summary/structure. No access to this external material type was attempted in this review; it was not acquired or read. This link matches the actual material type of the URL in the currently retained bibliographic entry. Historical access level: primary_article_full_text_on_repository. Medicine 99(9):e19232; sections 2.1–2.3, 3.1–3.3, Table 1 and discussion; Figure 1 timing. Report-specific historical access dates are unverified. The stored manuscript's evidence-review date, 2026-09-15, is not the date on which the original material was actually accessed. No access to external material was attempted and no original source was read in this review.",
          "material_id": "S04-M1",
          "url": "https://www.researchgate.net/publication/339621681_Assessment_of_biotin_interference_in_thyroid_function_tests",
          "bibliographic_url": "https://www.researchgate.net/publication/339621681_Assessment_of_biotin_interference_in_thyroid_function_tests",
          "access_attempted": false,
          "access_succeeded": false,
          "actually_read_this_run": false
        },
        {
          "material_type": "Registration version history",
          "public_status": "Unverified (no external lookup in this review)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "The input actually read in this review is the source JSON containing the retained bibliographic entry and Korean summary/structure. No access to this external material type was attempted in this review; it was not acquired or read. A separate actual URL for this material type is currently unverified. The original bibliographic link is an identifying reference and is not presented as the original source for this material type. Historical access level: primary_article_full_text_on_repository. Medicine 99(9):e19232; sections 2.1–2.3, 3.1–3.3, Table 1 and discussion; Figure 1 timing. Report-specific historical access dates are unverified. The stored manuscript's evidence-review date, 2026-09-15, is not the date on which the original material was actually accessed. No access to external material was attempted and no original source was read in this review.",
          "material_id": "S04-M2",
          "url": null,
          "bibliographic_url": "https://www.researchgate.net/publication/339621681_Assessment_of_biotin_interference_in_thyroid_function_tests",
          "access_attempted": false,
          "access_succeeded": false,
          "actually_read_this_run": false
        },
        {
          "material_type": "Protocol",
          "public_status": "Unverified (no external lookup in this review)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "The input actually read in this review is the source JSON containing the retained bibliographic entry and Korean summary/structure. No access to this external material type was attempted in this review; it was not acquired or read. A separate actual URL for this material type is currently unverified. The original bibliographic link is an identifying reference and is not presented as the original source for this material type. Historical access level: primary_article_full_text_on_repository. Medicine 99(9):e19232; sections 2.1–2.3, 3.1–3.3, Table 1 and discussion; Figure 1 timing. Report-specific historical access dates are unverified. The stored manuscript's evidence-review date, 2026-09-15, is not the date on which the original material was actually accessed. No access to external material was attempted and no original source was read in this review.",
          "material_id": "S04-M3",
          "url": null,
          "bibliographic_url": "https://www.researchgate.net/publication/339621681_Assessment_of_biotin_interference_in_thyroid_function_tests",
          "access_attempted": false,
          "access_succeeded": false,
          "actually_read_this_run": false
        },
        {
          "material_type": "Analysis plan (SAP)",
          "public_status": "Unverified (no external lookup in this review)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "The input actually read in this review is the source JSON containing the retained bibliographic entry and Korean summary/structure. No access to this external material type was attempted in this review; it was not acquired or read. A separate actual URL for this material type is currently unverified. The original bibliographic link is an identifying reference and is not presented as the original source for this material type. Historical access level: primary_article_full_text_on_repository. Medicine 99(9):e19232; sections 2.1–2.3, 3.1–3.3, Table 1 and discussion; Figure 1 timing. Report-specific historical access dates are unverified. The stored manuscript's evidence-review date, 2026-09-15, is not the date on which the original material was actually accessed. No access to external material was attempted and no original source was read in this review.",
          "material_id": "S04-M4",
          "url": null,
          "bibliographic_url": "https://www.researchgate.net/publication/339621681_Assessment_of_biotin_interference_in_thyroid_function_tests",
          "access_attempted": false,
          "access_succeeded": false,
          "actually_read_this_run": false
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://www.researchgate.net/publication/339621681_Assessment_of_biotin_interference_in_thyroid_function_tests"
        }
      ],
      "bibliographic_url": "https://www.researchgate.net/publication/339621681_Assessment_of_biotin_interference_in_thyroid_function_tests",
      "historical_access_level": "primary_article_full_text_on_repository",
      "historical_access_location": "Medicine 99(9):e19232; sections 2.1–2.3, 3.1–3.3, Table 1 and discussion; Figure 1 timing",
      "historical_access_date": null,
      "historical_source_review_date": "2026-09-15"
    },
    {
      "report_id": "S05",
      "title": "Ylli et al. 2021. Biotin Interference in Assays for Thyroid Hormones, Thyrotropin and Thyroglobulin",
      "url": "https://pubmed.ncbi.nlm.nih.gov/34042535/",
      "report_type": "PubMed abstract and figure captions (historical access)",
      "existence": "The scope comprises the current 12 bibliographic entries and the actual related retained manuscript/structure. Historical non-access to full texts and historically inherited extracts are distinguished from unattempted access in this review.",
      "acquired_read": "The relevant bibliographic entry, summary and structure in the stored manuscript were read. The linked external original materials were not acquired or read in this review.",
      "study_family": "F03",
      "independent_replication": false,
      "observed_result": "Record at the time of retention: 13 adults enrolled, 10 mg/day for 8 days, with measurements on day 1/day 8 before dosing and at 2 hours and 5 hours. The abstract supports Roche TSH changes and the greatest interference at 2 hours. Detailed TSH analysis n, full-text quantitative tables, exact bias/CI and funding/product roles are unverified; percentages from search summaries were not imported.",
      "result_level": "This is a transition of the KO/structured evidence, bibliography and historical access locations retained as of 2026-09-15. It is not external original-source reading, new numerical calculation or reassessment in this review.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "PubMed abstract and figure captions",
          "public_status": "Unverified (no external lookup in this review)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "The input actually read in this review is the source JSON containing the retained bibliographic entry and Korean summary/structure. No access to this external material type was attempted in this review; it was not acquired or read. This link matches the actual material type of the URL in the currently retained bibliographic entry. Historical access level: pubmed_abstract_and_figure_captions. Abstract Methods/Results; TSH figure caption; conflicts statement. Report-specific historical access dates are unverified. The stored manuscript's evidence-review date, 2026-09-15, is not the date on which the original material was actually accessed. No access to external material was attempted and no original source was read in this review.",
          "material_id": "S05-M1",
          "url": "https://pubmed.ncbi.nlm.nih.gov/34042535/",
          "bibliographic_url": "https://pubmed.ncbi.nlm.nih.gov/34042535/",
          "access_attempted": false,
          "access_succeeded": false,
          "actually_read_this_run": false
        },
        {
          "material_type": "Quantitative tables in the original article's full text",
          "public_status": "Unverified (no external lookup in this review)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "The input actually read in this review is the source JSON containing the retained bibliographic entry and Korean summary/structure. No access to this external material type was attempted in this review; it was not acquired or read. A separate actual URL for this material type is currently unverified. The original bibliographic link is an identifying reference and is not presented as the original source for this material type. Historical access level: pubmed_abstract_and_figure_captions. Abstract Methods/Results; TSH figure caption; conflicts statement. Report-specific historical access dates are unverified. The stored manuscript's evidence-review date, 2026-09-15, is not the date on which the original material was actually accessed. No access to external material was attempted and no original source was read in this review.",
          "material_id": "S05-M2",
          "url": null,
          "bibliographic_url": "https://pubmed.ncbi.nlm.nih.gov/34042535/",
          "access_attempted": false,
          "access_succeeded": false,
          "actually_read_this_run": false
        },
        {
          "material_type": "Original numerical supplement",
          "public_status": "Unverified (no external lookup in this review)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "The input actually read in this review is the source JSON containing the retained bibliographic entry and Korean summary/structure. No access to this external material type was attempted in this review; it was not acquired or read. A separate actual URL for this material type is currently unverified. The original bibliographic link is an identifying reference and is not presented as the original source for this material type. Historical access level: pubmed_abstract_and_figure_captions. Abstract Methods/Results; TSH figure caption; conflicts statement. Report-specific historical access dates are unverified. The stored manuscript's evidence-review date, 2026-09-15, is not the date on which the original material was actually accessed. No access to external material was attempted and no original source was read in this review.",
          "material_id": "S05-M3",
          "url": null,
          "bibliographic_url": "https://pubmed.ncbi.nlm.nih.gov/34042535/",
          "access_attempted": false,
          "access_succeeded": false,
          "actually_read_this_run": false
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://pubmed.ncbi.nlm.nih.gov/34042535/"
        }
      ],
      "bibliographic_url": "https://pubmed.ncbi.nlm.nih.gov/34042535/",
      "historical_access_level": "pubmed_abstract_and_figure_captions",
      "historical_access_location": "Abstract Methods/Results; TSH figure caption; conflicts statement",
      "historical_access_date": null,
      "historical_source_review_date": "2026-09-15"
    },
    {
      "report_id": "S06",
      "title": "NIH Office of Dietary Supplements: Biotin—Health Professional Fact Sheet",
      "url": "https://ods.od.nih.gov/factsheets/Biotin-HealthProfessional/",
      "report_type": "Historically inherited extract from an official NIH web document",
      "existence": "The scope comprises the current 12 bibliographic entries and the actual related retained manuscript/structure. Historical non-access to full texts and historically inherited extracts are distinguished from unattempted access in this review.",
      "acquired_read": "The relevant bibliographic entry, summary and structure in the stored manuscript were read. The linked external original materials were not acquired or read in this review.",
      "study_family": null,
      "independent_replication": false,
      "observed_result": "General background record at the time of retention: The scope is inherited original sources/extracts/access records for NIH ODS Table1, risks from excessive biotin and interactions with laboratory tests, refs9/38. No new search was conducted, and this was not counted as an independent TSH study or the same bias across all analytes.",
      "result_level": "This is a transition of the KO/structured evidence, bibliography and historical access locations retained as of 2026-09-15. It is not external original-source reading, new numerical calculation or reassessment in this review.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "Official NIH ODS web document",
          "public_status": "Unverified (no external lookup in this review)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "The input actually read in this review is the source JSON containing the retained bibliographic entry and Korean summary/structure. No access to this external material type was attempted in this review; it was not acquired or read. This link matches the actual material type of the URL in the currently retained bibliographic entry. Historical access level: inherited_official_extract. Table1; Health Risks from Excessive Biotin; Interactions with Laboratory Tests, refs9/38. Report-specific historical access dates are unverified. The stored manuscript's evidence-review date, 2026-09-15, is not the date on which the original material was actually accessed. No access to external material was attempted and no original source was read in this review.",
          "material_id": "S06-M1",
          "url": "https://ods.od.nih.gov/factsheets/Biotin-HealthProfessional/",
          "bibliographic_url": "https://ods.od.nih.gov/factsheets/Biotin-HealthProfessional/",
          "access_attempted": false,
          "access_succeeded": false,
          "actually_read_this_run": false
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://ods.od.nih.gov/factsheets/Biotin-HealthProfessional/"
        }
      ],
      "bibliographic_url": "https://ods.od.nih.gov/factsheets/Biotin-HealthProfessional/",
      "historical_access_level": "inherited_official_extract",
      "historical_access_location": "Table1; Health Risks from Excessive Biotin; Interactions with Laboratory Tests, refs9/38",
      "historical_access_date": null,
      "historical_source_review_date": "2026-09-15"
    },
    {
      "report_id": "S07",
      "title": "FDA: Biotin Interference with Troponin Lab Tests—Assays Subject to Biotin Interference",
      "url": "https://www.fda.gov/medical-devices/in-vitro-diagnostics/biotin-interference-troponin-lab-tests-assays-subject-biotin-interference",
      "report_type": "Historically inherited extract from an official FDA web document",
      "existence": "The scope comprises the current 12 bibliographic entries and the actual related retained manuscript/structure. Historical non-access to full texts and historically inherited extracts are distinguished from unattempted access in this review.",
      "acquired_read": "The relevant bibliographic entry, summary and structure in the stored manuscript were read. The linked external original materials were not acquired or read in this review.",
      "study_family": null,
      "independent_replication": false,
      "observed_result": "General background record at the time of retention: The opening safety statement and paragraphs on residual assay interference in the FDA troponin-testing document are inherited from an earlier extraction. This is not elevated to a new search or original-source reading in this review, or to independent TSH figures/studies.",
      "result_level": "This is a transition of the KO/structured evidence, bibliography and historical access locations retained as of 2026-09-15. It is not external original-source reading, new numerical calculation or reassessment in this review.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "Official FDA web document on troponin tests",
          "public_status": "Unverified (no external lookup in this review)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "The input actually read in this review is the source JSON containing the retained bibliographic entry and Korean summary/structure. No access to this external material type was attempted in this review; it was not acquired or read. This link matches the actual material type of the URL in the currently retained bibliographic entry. Historical access level: inherited_official_extract. Opening safety statement and paragraphs on residual assay interference. Report-specific historical access dates are unverified. The stored manuscript's evidence-review date, 2026-09-15, is not the date on which the original material was actually accessed. No access to external material was attempted and no original source was read in this review.",
          "material_id": "S07-M1",
          "url": "https://www.fda.gov/medical-devices/in-vitro-diagnostics/biotin-interference-troponin-lab-tests-assays-subject-biotin-interference",
          "bibliographic_url": "https://www.fda.gov/medical-devices/in-vitro-diagnostics/biotin-interference-troponin-lab-tests-assays-subject-biotin-interference",
          "access_attempted": false,
          "access_succeeded": false,
          "actually_read_this_run": false
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://www.fda.gov/medical-devices/in-vitro-diagnostics/biotin-interference-troponin-lab-tests-assays-subject-biotin-interference"
        }
      ],
      "bibliographic_url": "https://www.fda.gov/medical-devices/in-vitro-diagnostics/biotin-interference-troponin-lab-tests-assays-subject-biotin-interference",
      "historical_access_level": "inherited_official_extract",
      "historical_access_location": "Opening safety statement and paragraphs on residual assay interference",
      "historical_access_date": null,
      "historical_source_review_date": "2026-09-15"
    },
    {
      "report_id": "S08",
      "title": "Roche Elecsys TSH method sheet, US, 2024-10 V2.0",
      "url": "https://elabdoc-prod.roche.com/eLD/api/downloads/4f54ba6c-732d-ef11-2591-005056a71a5d?countryIsoCode=us",
      "report_type": "Official Roche reagent method PDF (historical access)",
      "existence": "The scope comprises the current 12 bibliographic entries and the actual related retained manuscript/structure. Historical non-access to full texts and historically inherited extracts are distinguished from unattempted access in this review.",
      "acquired_read": "The relevant bibliographic entry, summary and structure in the stored manuscript were read. The linked external original materials were not acquired or read in this review.",
      "study_family": "A01",
      "independent_replication": false,
      "observed_result": "Record at the time of retention: US 2024-10 V2.0, 08429324501V2.0, product ref 08429324160 is a method document for cobas e411/e601/e602. For biotin ≤1200 ng/mL, at TSH ≤0.2 µIU/mL the deviation criterion is ≤0.02 µIU/mL; at higher TSH it is ≤10%. This is a manufacturer analytical document. It does not guarantee a safe oral dose in humans or bias 0, verify every laboratory's installed version, or establish identity with historical reagents.",
      "result_level": "This is a transition of the KO/structured evidence, bibliography and historical access locations retained as of 2026-09-15. It is not external original-source reading, new numerical calculation or reassessment in this review.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "Official Roche reagent method PDF",
          "public_status": "Unverified (no external lookup in this review)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "The input actually read in this review is the source JSON containing the retained bibliographic entry and Korean summary/structure. No access to this external material type was attempted in this review; it was not acquired or read. This link matches the actual material type of the URL in the currently retained bibliographic entry. Historical access level: official_full_pdf. PDF p1 product/platform/test principle; pp2–3 Limitations–interference; p3 measurement range. Report-specific historical access dates are unverified. The stored manuscript's evidence-review date, 2026-09-15, is not the date on which the original material was actually accessed. No access to external material was attempted and no original source was read in this review.",
          "material_id": "S08-M1",
          "url": "https://elabdoc-prod.roche.com/eLD/api/downloads/4f54ba6c-732d-ef11-2591-005056a71a5d?countryIsoCode=us",
          "bibliographic_url": "https://elabdoc-prod.roche.com/eLD/api/downloads/4f54ba6c-732d-ef11-2591-005056a71a5d?countryIsoCode=us",
          "access_attempted": false,
          "access_succeeded": false,
          "actually_read_this_run": false
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://elabdoc-prod.roche.com/eLD/api/downloads/4f54ba6c-732d-ef11-2591-005056a71a5d?countryIsoCode=us"
        }
      ],
      "bibliographic_url": "https://elabdoc-prod.roche.com/eLD/api/downloads/4f54ba6c-732d-ef11-2591-005056a71a5d?countryIsoCode=us",
      "historical_access_level": "official_full_pdf",
      "historical_access_location": "PDF p1 product/platform/test principle; pp2–3 Limitations–interference; p3 measurement range",
      "historical_access_date": null,
      "historical_source_review_date": "2026-09-15"
    },
    {
      "report_id": "S09",
      "title": "AACC Academy guidance: Biotin Interference in Laboratory Tests",
      "url": "https://myadlm.org/science-and-research/academy-guidance/biotin-interference-in-laboratory-tests",
      "report_type": "Full HTML text of official AACC guidance (historical access)",
      "existence": "The scope comprises the current 12 bibliographic entries and the actual related retained manuscript/structure. Historical non-access to full texts and historically inherited extracts are distinguished from unattempted access in this review.",
      "acquired_read": "The relevant bibliographic entry, summary and structure in the stored manuscript were read. The linked external original materials were not acquired or read in this review.",
      "study_family": null,
      "independent_replication": false,
      "observed_result": "General background record at the time of retention: This is a historical record of checking the locations of mechanisms, assay specificity, renal elimination and recommendations in the 2020-01-13 AACC guidance. Numerical recommendations not embedded in the current JSON are not newly presented or used as individual stopping intervals, testing schedules or treatment changes.",
      "result_level": "This is a transition of the KO/structured evidence, bibliography and historical access locations retained as of 2026-09-15. It is not external original-source reading, new numerical calculation or reassessment in this review.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "Full HTML text of official AACC guidance",
          "public_status": "Unverified (no external lookup in this review)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "The input actually read in this review is the source JSON containing the retained bibliographic entry and Korean summary/structure. No access to this external material type was attempted in this review; it was not acquired or read. This link matches the actual material type of the URL in the currently retained bibliographic entry. Historical access level: official_full_text. 2020-01-13 guidance; mechanisms, assay specificity, renal elimination and recommendations. Report-specific historical access dates are unverified. The stored manuscript's evidence-review date, 2026-09-15, is not the date on which the original material was actually accessed. No access to external material was attempted and no original source was read in this review.",
          "material_id": "S09-M1",
          "url": "https://myadlm.org/science-and-research/academy-guidance/biotin-interference-in-laboratory-tests",
          "bibliographic_url": "https://myadlm.org/science-and-research/academy-guidance/biotin-interference-in-laboratory-tests",
          "access_attempted": false,
          "access_succeeded": false,
          "actually_read_this_run": false
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://myadlm.org/science-and-research/academy-guidance/biotin-interference-in-laboratory-tests"
        }
      ],
      "bibliographic_url": "https://myadlm.org/science-and-research/academy-guidance/biotin-interference-in-laboratory-tests",
      "historical_access_level": "official_full_text",
      "historical_access_location": "2020-01-13 guidance; mechanisms, assay specificity, renal elimination and recommendations",
      "historical_access_date": null,
      "historical_source_review_date": "2026-09-15"
    },
    {
      "report_id": "S10",
      "title": "2026 ETA guideline on interference in immunoassay measurements used in assessment of thyroid function",
      "url": "https://pubmed.ncbi.nlm.nih.gov/42466561/",
      "report_type": "PubMed bibliographic record; historical record of full-text non-access",
      "existence": "The scope comprises the current 12 bibliographic entries and the actual related retained manuscript/structure. Historical non-access to full texts and historically inherited extracts are distinguished from unattempted access in this review.",
      "acquired_read": "The relevant bibliographic entry, summary and structure in the stored manuscript were read. The linked external original materials were not acquired or read in this review.",
      "study_family": null,
      "independent_replication": false,
      "observed_result": "Record at the time of retention: Guideline metadata for DOI 10.1530/ETJ-26-0011, PMID 42466561 were discovered, but the publisher full-text request failed at that time. No current access was attempted, and no detailed performance figures/new recommendations were generated from the guideline.",
      "result_level": "This is a transition of the KO/structured evidence, bibliography and historical access locations retained as of 2026-09-15. It is not external original-source reading, new numerical calculation or reassessment in this review.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "PubMed bibliographic record for the guideline",
          "public_status": "Unverified (no external lookup in this review)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "The input actually read in this review is the source JSON containing the retained bibliographic entry and Korean summary/structure. No access to this external material type was attempted in this review; it was not acquired or read. This link matches the actual material type of the URL in the currently retained bibliographic entry. Historical access level: metadata_discovered_full_text_inaccessible. Search metadata only; publisher full text request failed. Report-specific historical access dates are unverified. The stored manuscript's evidence-review date, 2026-09-15, is not the date on which the original material was actually accessed. No access to external material was attempted and no original source was read in this review.",
          "material_id": "S10-M1",
          "url": "https://pubmed.ncbi.nlm.nih.gov/42466561/",
          "bibliographic_url": "https://pubmed.ncbi.nlm.nih.gov/42466561/",
          "access_attempted": false,
          "access_succeeded": false,
          "actually_read_this_run": false
        },
        {
          "material_type": "Publisher's full text of the guideline",
          "public_status": "Unverified (no external lookup in this review)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "The input actually read in this review is the source JSON containing the retained bibliographic entry and Korean summary/structure. No access to this external material type was attempted in this review; it was not acquired or read. A separate actual URL for this material type is currently unverified. The original bibliographic link is an identifying reference and is not presented as the original source for this material type. Historical access level: metadata_discovered_full_text_inaccessible. Search metadata only; publisher full text request failed. Report-specific historical access dates are unverified. The stored manuscript's evidence-review date, 2026-09-15, is not the date on which the original material was actually accessed. No access to external material was attempted and no original source was read in this review.",
          "material_id": "S10-M2",
          "url": null,
          "bibliographic_url": "https://pubmed.ncbi.nlm.nih.gov/42466561/",
          "access_attempted": false,
          "access_succeeded": false,
          "actually_read_this_run": false
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://pubmed.ncbi.nlm.nih.gov/42466561/"
        }
      ],
      "bibliographic_url": "https://pubmed.ncbi.nlm.nih.gov/42466561/",
      "historical_access_level": "metadata_discovered_full_text_inaccessible",
      "historical_access_location": "Search metadata only; publisher full text request failed",
      "historical_access_date": null,
      "historical_source_review_date": "2026-09-15"
    },
    {
      "report_id": "S11",
      "title": "Biotin interference in TSH, FT4, and FT3 assays based on the LOCI technology: identifying interference by dilution",
      "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC6818550/",
      "report_type": "PMC entry URL for the original article; historical search metadata only",
      "existence": "The scope comprises the current 12 bibliographic entries and the actual related retained manuscript/structure. Historical non-access to full texts and historically inherited extracts are distinguished from unattempted access in this review.",
      "acquired_read": "The relevant bibliographic entry, summary and structure in the stored manuscript were read. The linked external original materials were not acquired or read in this review.",
      "study_family": null,
      "independent_replication": false,
      "observed_result": "Record at the time of retention: The candidate identified by DOI 10.1002/jcla.22667, PMCID PMC6818550 concerns LOCI TSH/FT4/FT3 and is limited to discovery metadata. Historical full-text access limitations left the original concentration-response tables unverified, and the PMC original text was not opened in this review.",
      "result_level": "This is a transition of the KO/structured evidence, bibliography and historical access locations retained as of 2026-09-15. It is not external original-source reading, new numerical calculation or reassessment in this review.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "Full HTML text of the original article on PMC (not read in the current review)",
          "public_status": "Unverified (no external lookup in this review)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "The input actually read in this review is the source JSON containing the retained bibliographic entry and Korean summary/structure. No access to this external material type was attempted in this review; it was not acquired or read. This link matches the actual material type of the URL in the currently retained bibliographic entry. Historical access level: search_metadata_only_full_text_inaccessible. Discovery metadata; no primary concentration-response table verified. Report-specific historical access dates are unverified. The stored manuscript's evidence-review date, 2026-09-15, is not the date on which the original material was actually accessed. No access to external material was attempted and no original source was read in this review.",
          "material_id": "S11-M1",
          "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC6818550/",
          "bibliographic_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC6818550/",
          "access_attempted": false,
          "access_succeeded": false,
          "actually_read_this_run": false
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC6818550/"
        }
      ],
      "bibliographic_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC6818550/",
      "historical_access_level": "search_metadata_only_full_text_inaccessible",
      "historical_access_location": "Discovery metadata; no primary concentration-response table verified",
      "historical_access_date": null,
      "historical_source_review_date": "2026-09-15"
    },
    {
      "report_id": "S12",
      "title": "Biotin interference in routine clinical immunoassays",
      "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC12099460/",
      "report_type": "PMC entry URL for the original article; historical search metadata only",
      "existence": "The scope comprises the current 12 bibliographic entries and the actual related retained manuscript/structure. Historical non-access to full texts and historically inherited extracts are distinguished from unattempted access in this review.",
      "acquired_read": "The relevant bibliographic entry, summary and structure in the stored manuscript were read. The linked external original materials were not acquired or read in this review.",
      "study_family": null,
      "independent_replication": false,
      "observed_result": "Record at the time of retention: The candidate with DOI 10.1016/j.plabm.2025.e00472, PMCID PMC12099460 is limited to discovery metadata. The record states that a PMC challenge blocked original extraction at that time; this is not an access failure in this review. No quantitative bias, denominators or independent study identities were newly generated.",
      "result_level": "This is a transition of the KO/structured evidence, bibliography and historical access locations retained as of 2026-09-15. It is not external original-source reading, new numerical calculation or reassessment in this review.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "Full HTML text of the original article on PMC (not read in the current review)",
          "public_status": "Unverified (no external lookup in this review)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "The input actually read in this review is the source JSON containing the retained bibliographic entry and Korean summary/structure. No access to this external material type was attempted in this review; it was not acquired or read. This link matches the actual material type of the URL in the currently retained bibliographic entry. Historical access level: search_metadata_only_full_text_inaccessible. Discovery metadata; PMC challenge prevented primary extraction. Report-specific historical access dates are unverified. The stored manuscript's evidence-review date, 2026-09-15, is not the date on which the original material was actually accessed. No access to external material was attempted and no original source was read in this review.",
          "material_id": "S12-M1",
          "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC12099460/",
          "bibliographic_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC12099460/",
          "access_attempted": false,
          "access_succeeded": false,
          "actually_read_this_run": false
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC12099460/"
        }
      ],
      "bibliographic_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC12099460/",
      "historical_access_level": "search_metadata_only_full_text_inaccessible",
      "historical_access_location": "Discovery metadata; PMC challenge prevented primary extraction",
      "historical_access_date": null,
      "historical_source_review_date": "2026-09-15"
    }
  ],
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility criteria and reasons for changes, and distinguish variations in the intervention.",
      "review_level": "This is a comparison of actual copies/SHA for case 1585's 5 original methodology HTML files, retaining their original bytes, and historical reuse of the principles from that time. It is not new reading of full methods texts, implementation of formal assessment tools or clinical certification."
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish and link studies and reports, and do not omit a study solely because its outcomes are not reported.",
      "review_level": "This is a comparison of actual copies/SHA for case 1585's 5 original methodology HTML files, retaining their original bytes, and historical reuse of the principles from that time. It is not new reading of full methods texts, implementation of formal assessment tools or clinical certification."
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Hold the outcome and effect of interest fixed, then assess randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "This is a comparison of actual copies/SHA for case 1585's 5 original methodology HTML files, retaining their original bytes, and historical reuse of the principles from that time. It is not new reading of full methods texts, implementation of formal assessment tools or clinical certification."
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "This is a comparison of actual copies/SHA for case 1585's 5 original methodology HTML files, retaining their original bytes, and historical reuse of the principles from that time. It is not new reading of full methods texts, implementation of formal assessment tools or clinical certification."
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Questions about harms may require designs, populations and follow-up different from efficacy questions. Case reports do not establish incidence.",
      "review_level": "This is a comparison of actual copies/SHA for case 1585's 5 original methodology HTML files, retaining their original bytes, and historical reuse of the principles from that time. It is not new reading of full methods texts, implementation of formal assessment tools or clinical certification."
    }
  ],
  "status_dictionary": {
    "Met": "The record meets the specified narrow conditions for measurement identity, attribution/units, version/reading and display. This does not establish efficacy, absence of interference or individual safety, or verify that the external full text has been checked in the current review.",
    "Partly verified": "Relevant retained observations exist, but some necessary methods, reagents/versions, denominators, quantitative intervals or comparisons against original sources remain unverified.",
    "Unverified": "The value could not be established from the currently retained materials and the scope verified at that time. This does not mean bias 0, normality, absence/failure of data or absence of interference.",
    "Not reported": "Used only within the scope of non-reporting in sections actually read or in the historical summaries currently specified. It is not extended to entire external full texts that remain unread in this review.",
    "Conflicting information": "Specify retained discrepancies or possible errors concerning the same fact in each row. Different platforms, time points or formal contrasts/simple differences do not in themselves constitute a conflict.",
    "Inaccessible": "Used only for an actual access failure in this review. No external access was attempted in this review, so historical failures are not carried over as current status.",
    "Review incomplete": "Limited to the scope in which comparison against current external materials has not been performed. It does not mean that the entire review of the retained JSON and model, which was actually completed, is incomplete.",
    "Not applicable": "Limited to other analytes outside the required outcomes of the narrow TSH question. This is not a substitute for unread/unverified status, or certification of no interference or safety."
  },
  "study_overlap": {
    "state": "F01 (S01, S02, S03): Direct oral-exposure and serum-TSH measurement evidence; not used for efficacy scoring. This is the same data family in the existing evidence. Supplements/corrections/platforms, time points and doses are not added as independent participants/studies. / F02 (S04): Direct oral-exposure measurement evidence; interpreted only by time point and platform. This is the same data family in the existing evidence. Supplements/corrections/platforms, time points and doses are not added as independent participants/studies. / F03 (S05): Directional corroboration; full-text quantitative tables unverified. This is the same data family in the existing evidence. Supplements/corrections/platforms, time points and doses are not added as independent participants/studies. / A01 (S08): For checking the current reagent-version boundary; not counted as an independent human replication. This is the existing manufacturer analytical-document family. It is not counted as human participants/independent replication. The 12 bibliographic entries, multiple platforms, doses, time points, supplements and correction documents are not added together as independent human replications. The abstract level of F03 is distinguished from the manufacturer analytical document A01, and the total number of unique analyzed participants remains unverified.",
    "unique_trial_count": null,
    "unique_participant_count": null,
    "reason": "F01 (S01, S02, S03): Direct oral-exposure and serum-TSH measurement evidence; not used for efficacy scoring. This is the same data family in the existing evidence. Supplements/corrections/platforms, time points and doses are not added as independent participants/studies. / F02 (S04): Direct oral-exposure measurement evidence; interpreted only by time point and platform. This is the same data family in the existing evidence. Supplements/corrections/platforms, time points and doses are not added as independent participants/studies. / F03 (S05): Directional corroboration; full-text quantitative tables unverified. This is the same data family in the existing evidence. Supplements/corrections/platforms, time points and doses are not added as independent participants/studies. / A01 (S08): For checking the current reagent-version boundary; not counted as an independent human replication. This is the existing manufacturer analytical-document family. It is not counted as human participants/independent replication. The 12 bibliographic entries, multiple platforms, doses, time points, supplements and correction documents are not added together as independent human replications. The abstract level of F03 is distinguished from the manufacturer analytical document A01, and the total number of unique analyzed participants remains unverified."
  },
  "history": [
    {
      "date": "2026-11-03",
      "kind": "Separation of public-facing display and data",
      "view_version": "1.0",
      "change": "The 40 review items for the existing measurement question have been transferred to the public-facing display and data. Original verification statuses, figures, units, versions and unverified information are retained, without a new clinical search, scoring or reassessment."
    }
  ],
  "measurement_only": true,
  "question_type": "measurement",
  "page_type": "measurement",
  "efficacy_grade": "not_applicable",
  "efficacy_score": "not_applicable",
  "efficacy_axes": "not_applicable",
  "display_contract": {
    "forbid_efficacy_badge": true,
    "forbid_aggregate_rating": true,
    "forbid_universal_stopping_interval": true,
    "unknown_rendering": "Show the reason for unknown status; never convert it to 0, normal, absent, or false."
  },
  "measurement_context": {
    "question": "After oral biotin exposure, what direction and magnitude of measurement bias were observed in specific serum TSH assays in healthy adults, compared with the same people before exposure/after washout or comparator platforms using specimens from the same time point? Distinguish findings by platform, reagent version, dose, dosing duration and time from the last dose to blood draw.",
    "outside_scope": "Thyroid function/treatment effects, diagnostic accuracy/actual misdiagnosis/patient harm rates, all analytes/reagents, a universal stopping interval, and extensions to safe human doses/special populations are separate questions.",
    "condition_status_meaning": "The preceding verification statuses describe the verification scope of each narrow record condition; they are not badges of efficacy, absence of interference or individual safety.",
    "safety_warning": "The original safety status is Warning. This reflects the possibility that falsely low TSH could lead to interpretation errors; the direct observations are assay-specific bias and reference-limit crossing. The incidence of actual patient harm is not an established result.",
    "document_quality": "The retained document-quality record is B, separate from the magnitude of the measurement effect or an individual safety grade."
  },
  "language": "en",
  "translation_date": "2026-11-03"
}