Best practices in mitigating the risk of biotin interference with laboratory testing

Area of Science:

• Clinical Chemistry
• Laboratory Medicine
• Biochemistry

Background:

• High-dose biotin supplements and clinical trials are increasing concerns about biotin interference with in vitro diagnostic tests.
• Biotin interference can affect various immunoassays, including those for thyroid hormones, reproductive hormones, cardiac markers, and immunosuppressive drugs.
• Suspected biotin interference has been reported to the US Food and Drug Administration, highlighting the clinical relevance of this issue.

Purpose of the Study:

• To address the growing concern of biotin interference with immunoassays due to increased high-dose biotin usage.
• To propose a best practice workflow for laboratory scientists to identify and manage biotin interference in discrepant immunoassay results.
• To emphasize the need for improved manufacturer guidance and education for patients and healthcare professionals regarding biotin interference.

Main Methods:

• Evaluation of discrepant immunoassay results using a proposed best practice workflow.
• Workflow includes serial dilution, retesting after biotin clearance or on an alternate platform, and biotin confirmation via depletion or direct measurement.
• Review of reported cases and challenges associated with biotin interference, particularly in thyroid hormone assays.

Main Results:

• Biotin interference can lead to misinterpretation of immunoassay results, potentially causing misdiagnosis, such as in Graves' disease.
• Clinically relevant interference occurs when high blood biotin concentrations coincide with assay sensitivity to biotin.
• The proposed workflow provides a systematic approach for laboratories to investigate and confirm biotin interference.

Conclusions:

• Suspecting biotin interference is vital when immunoassay results contradict clinical findings.
• Implementing standardized protocols and enhancing awareness among patients, healthcare providers, and laboratory staff are essential for accurate diagnostics.
• Further development of best practice guidance is needed for the prevention, detection, and management of biotin interference in clinical laboratories.