An Experimental Study on the Effect of Biotin on Measurement of Thyroid Function Test in Healthy Adults
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Abstract
BACKGROUND: The inaccuracy of Streptavidin-based diagnostic tests in a laboratory may be associated with the ingestion of over-the-counter biotin. In the case of competitive immunoassays, which are usually used for low molecular weight targets (such as T4, T3, and cortisol), biotin interference causes an erroneously high result. In immunometric (sandwich) assays such as TSH, it gives a misleadingly low result.
OBJECTIVES: The aim of this study was to assess the effect of consuming 10 mg per day of biotin on thyroid function test interference.
METHODS: This experimental research study was done at Somdech Phranangchao Sirikit Hospital from August 2023 to January 2024. The study enrolled healthy volunteers aged 18 years or older, who were instructed to take 10 mg/d of biotin. Thyroid function tests were measured at baseline, during biotin supplementation, and 7 days after withdrawal. The primary outcome was percent change in mean FT3, FT4 and TSH. Laboratory results were compared with baseline (day 0) measures on the 7th day of biotin treatment and 7 days after stopping biotin. The proportion of patients with biotin interference (Beckman UniCel DxI 800 vs Roche Cobas Elecsys e801) was assessed as a key secondary outcome.
RESULTS: A total of 25 participants were enrolled. After biotin supplementation, there was a significant increase in FT3 and FT4 in the Beckman group (1.43 [95% CI 0.11, 2.75]; p=0.04), (0.55 [95% CI 0.16, 0.95]; p=0.008) compared with baseline, which returned to baseline 7 days after biotin washout. No difference in the Roche Hyperthyroid pattern from biotin interference occurred in 6 of 25 patients (24%) in the Beckman assays.
CONCLUSIONS: Biotin can interfere with thyroid laboratory tests. It is also necessary to stop taking biotin for at least 7 days before testing.
Thaiclinicaltrials.org number, TCTR20240411004
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McBride M, Dasgupta A. Significant interference of biotin in thyroid function tests using Beckman analyzer: how to identify such interferences?. Ann Clin Lab Sci 2023;53:130-3.