Sense and nonsense concerning biotin interference in laboratory tests

Area of Science:

• Clinical Chemistry
• Biotechnology
• Diagnostic Assays

Background:

• Biotin supplementation is increasingly popular, raising concerns about its interference with immunoassays.
• This interference can lead to misdiagnosis, particularly with high-dose biotin therapy used in conditions like multiple sclerosis (MS).

Purpose of the Study:

• To review the potential dangers associated with biotin usage in laboratory diagnostics.
• To explore countermeasures and strategies to mitigate biotin interference in immunoassays.

Main Methods:

• Analysis of how different immunoassay designs (sandwich vs. competitive) are affected by biotin.
• Identification of specific biomarkers susceptible to biotin interference, including hormones and tumor markers.
• Evaluation of platform-dependent variations in biotin interference.

Main Results:

• Biotin can cause analytical errors, leading to falsely lowered or elevated results depending on the assay type.
• Numerous biomarkers, including thyroid hormones, reproductive hormones, and vitamins, are susceptible to interference.
• While some assays are becoming more robust, certain tests like tumor markers and ß-hCG remain largely unaffected.

Conclusions:

• Patient education and timing of sample collection can help minimize peak biotin levels.
• Selecting appropriate immunoassays and implementing biotin removal steps are crucial for accurate results.
• Managing biotin interference is challenging in patients requiring high-dose biotin therapy, such as those with MS.