On September 29, 2025, Health Canada issued an important advisory warning healthcare professionals, clinical teams, and regulatory personnel about the risks of biotin supplementation interfering with laboratory test results. Biotin, commonly found in vitamins such as B7 and prenatal supplements, is reported to cause inaccuracies in diagnostic tests. This information is crucial for ensuring patient safety and maintaining the reliability of diagnostic procedures.
What changed?
Health Canada has highlighted the interference of biotin with various immunoassays, particularly those relying on biotin-streptavidin technology. The spike in false test results has raised concerns across lab testing domains, including hormone levels, cardiac markers, and other critical biomarkers. Clinicians and lab teams must now consider biotin intake as a potential variable when diagnosing patients.
Who is affected?
This issue primarily affects patients who consume high doses of biotin supplements—whether for hair, skin, and nail growth or due to medical advice. Laboratories, clinicians, and regulatory teams involved in diagnostic test manufacturing and oversight are directly impacted. Failure to account for biotin’s interference could lead to incorrect diagnoses, delayed treatments, or unnecessary interventions.
Scientific and diagnostic impact
Which tests are most affected?
Tests designed for endocrine, cardiovascular, and infectious diseases are particularly vulnerable. Biotin interference can lead to false negatives or positives, which compromise clinical decision-making.
Why does biotin interfere?
Biotin, at elevated levels from supplements, binds to streptavidin—a protein used in many immunoassays. This binding disrupts assay processes, leading to misreported test values.
Key warning for manufacturers
Regulatory and quality teams overseeing medical device and diagnostic product development must ensure immunoassays are tested for biotin interference. Consider incorporating warnings about biotin intake on product labeling.
Frequently Asked Questions
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What should patients do?
Patients should inform healthcare professionals about any biotin supplementation during medical visits.
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How can labs mitigate this risk?
Laboratories should inquire about biotin intake and use alternative test methods for patients with high exposure.
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Should biotin intake be disclosed?
Yes, clinicians must ask patients about dietary and supplement habits to ensure accurate diagnostics.
Conclusion
Biotin supplementation poses a significant challenge in diagnostic testing accuracy. Regulatory teams and clinicians must remain vigilant, conducting patient surveys and updating testing protocols to minimize risk. Manufacturers must assess biotin susceptibility during product design. Together, these steps protect both patients and lab testing integrity.
Disclaimer
This article provides general information on Health Canada’s advisory and its implications for medical diagnostics. It is not intended as legal advice or a regulatory submission guideline.
Official Health Canada resource
For full information about the announcement, see the link below.