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Electrochemiluminescence Assays for Human Islet Autoantibodies
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Interference in thyroid function tests using the electrochemiluminescence immunoassay

Chisako Imamura, Eijun Nishihara, Shuji Fukata

    European Thyroid Journal
    |March 23, 2026
    PubMed

    Insights

    Rare assay interferences in thyroid function tests can cause misdiagnosis. Free triiodothyronine (FT3) assays are most susceptible, highlighting the need for physician-laboratory collaboration to ensure accurate thyroid testing.

    Area of Science:

    • Clinical Chemistry
    • Endocrinology
    • Laboratory Medicine

    Background:

    • Electrochemiluminescence immunoassays (ECLIAs) are standard for thyroid function testing.
    • Assay interferences, though rare, can lead to significant diagnostic errors.

    Purpose of the Study:

    • To determine the frequency and types of assay interferences in thyrotropin (TSH), free thyroxine (FT4), and free triiodothyronine (FT3) measurements using the Roche ECLIA.
    • To assess the impact of these interferences on patient diagnosis and treatment.

    Main Methods:

    • Retrospective analysis of 124,615 thyroid function tests conducted between 2019 and 2023.
    • Identification of suspected interferences based on clinical-laboratory discrepancies and method comparisons.
    • Validation of confirmed interference cases.

    Main Results:

    • 71 cases of confirmed assay interference were identified across TSH, FT4, and FT3 tests.
    • Free triiodothyronine (FT3) assays showed the highest interference rate (0.064%), primarily due to idiotype and anti-streptavidin antibodies.
    • Macro-TSH was observed in six cases, potentially leading to inappropriate levothyroxine treatment.

    Conclusions:

    • Free triiodothyronine (FT3) testing is most vulnerable to assay interference.
    • Recognizing hormonal imbalances is crucial for detecting interferences, often before clinical symptoms appear.
    • Enhanced awareness of interference patterns and strong physician-laboratory communication are vital for accurate thyroid function testing and preventing misdiagnosis.
    Abstract

    Keywords:
    anti-T3 monoclonal antibodiesassay interferenceelectrochemiluminescence immunoassaymacro-thyroid-stimulating hormonethyroid function test

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