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A Large-Scale Study Identifies a TgAb Interference Threshold for Thyroglobulin Immunoassays Using Segmented

Qianhui Liu1, Lan You1, Heye Lv1

  • 1Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, China.

The Journal of Applied Laboratory Medicine
|June 16, 2026
PubMed
Summary
This summary is machine-generated.

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A new threshold for anti-thyroglobulin antibodies (TgAbs) near 48 U/mL on the Roche e801 platform helps accurately interpret thyroglobulin (Tg) levels in differentiated thyroid cancer (DTC) follow-up. This finding addresses interference issues in Tg immunoassays.

Area of Science:

  • Endocrinology
  • Clinical Chemistry
  • Oncology

Background:

  • Thyroglobulin (Tg) measurement is crucial for monitoring differentiated thyroid cancer (DTC).
  • Anti-thyroglobulin antibodies (TgAbs) can interfere with Tg immunoassays, leading to inaccurate results.
  • Existing TgAb cutoffs are inconsistent, necessitating an assay-specific interference threshold.

Purpose of the Study:

  • To establish a reliable TgAb interference threshold for Tg immunoassay interpretation on the Roche cobas e801 platform.
  • To validate this threshold using clinical data from papillary thyroid carcinoma (PTC) patients.

Main Methods:

  • Analysis of 85,949 euthyroid health-screening records using segmented linear regression to estimate a TgAb interference threshold.
  • External validation using 125 TgAb-positive PTC patients with receiver operating characteristic (ROC) analyses.

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  • Two ROC analyses were performed comparing different patient groups based on TgAb levels and recurrence status.
  • Main Results:

    • A population-derived TgAb interference threshold of 48.1 U/mL (95% CI, 45.1-50.6) was identified.
    • Above this threshold, Tg values showed a tendency towards lower ranges with increased asymmetry.
    • ROC analyses in the PTC cohort yielded thresholds of 45.64 U/mL and 50.14 U/mL, demonstrating strong internal stability and clinical relevance.

    Conclusions:

    • A TgAb level around 48 U/mL serves as a practical interference threshold for Tg immunoassay interpretation on the Roche cobas e801.
    • This threshold effectively stratifies Tg interpretability in DTC follow-up.
    • The established threshold aligns with ROC-derived cutoffs in TgAb-positive PTC patients, confirming its clinical utility.