NEW YORK (360Dx) – The US Food and Drug Administration today issued a draft guidance that provides recommendations on testing for biotin interference with in vitro diagnostic devices.
Today's draft guidance, building on a safety communication that the agency issued in 2017, provides additional recommendations to IVD manufacturers about testing for biotin interference as well as recommendations about communicating the results of such testing to users of diagnostic tests.
Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement that the FDA issued the draft guidance "to help assure the accuracy of select in vitro diagnostics testing samples from individuals using biotin."
Biotin, also known as vitamin B7, is a water-soluble vitamin often found in multivitamins, prenatal vitamins, and dietary supplements marketed for hair, skin, and nail growth.
Many diagnostic tests use biotin technology due to its ability to bind to specific proteins that can be measured to detect certain health conditions. For example, biotin is used in hormone tests and cardiac-health tests that use troponin as a biomarker.
Ingested at high levels by patients taking dietary supplements, biotin can cause "clinically significant incorrect lab test results such as falsely high or falsely low results, depending on the test," the FDA said.
The FDA said that it will continue its work with stakeholders to better understand biotin interference with laboratory tests, including working with manufacturers as they address the issue in designing and developing tests that use biotin technology.
Its safety communication issued in 2017 provided recommendations for patients, healthcare professionals, and laboratory personnel to mitigate potential biotin interference.