FDA warns of biotin interference in diagnostic troponin tests

The FDA issued a safety communication Nov. 5 reminding the public, healthcare providers and lab workers that the common supplement vitamin B7, or biotin, can interfere with certain diagnostic tests, including troponin tests that can be integral to a heart attack diagnosis.

Troponin, a cardiac biomarker that’s gained popularity in recent years as a tool for identifying individuals at risk for MI, has been implicated in this issue since 2017, when the FDA first issued a statement about the possibility of biotin interference in troponin assays. The agency said some manufacturers have taken steps to resolve the problem, but a handful of tests—including those developed by International Point of Care, Inc., Nano-Ditech Corporation, Princeton Biomeditech Corp., Roche Diagnostics and Siemens Healthcare Diagnostics—could still be subject to interference.

“While there are troponin tests on the market that are not affected by this interference, and several for which manufacturers have already addressed this issue, others remain on the market with the potential for harmful interference,” Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological  Health at the FDA’s Center for Devices and Radiological Health, said in the agency’s latest statement. “As part of our commitment to protecting public health and protecting patients, we’re communicating today to be transparent about the affected tests and provide as much detail as possible to the public.”

Biotin is a water-soluble vitamin found commonly in multivitamins, prenatal vitamins and dietary supplements marketed for hair, skin and nail growth, the FDA said. Many supplements could contain up to 650 times the recommended daily intake of biotin, leading to false highs or false lows when detected in diagnostic lab tests.

The FDA said that while it’s concerned about a number of diagnostic tests, troponin assays are a main target because faulty results could lead to a missed MI diagnosis and “potentially serious health implications.”

The agency is maintaining a list of tests that, as of Nov. 12, are still subject to biotin interference.

“The FDA will continue engaging with manufacturers as they work to address this interference and will update the list of troponin tests subject to biotin interference as appropriate,” the agency’s Nov. 5 statement reads. “Additionally, the agency is reminding patients and healthcare providers to discuss all supplement use.”