The U.S. Food and Drug Administration (FDA) issued a draft guidance: Testing for Biotin Interference in In Vitro Diagnostic Devices. This draft guidance provides recommendations on the testing for interference by biotin on the performance of in vitro diagnostic devices.
Biotin, also known as vitamin B7, is a water-soluble vitamin often found in multi-vitamins, prenatal vitamins and dietary supplements marketed for hair, skin and nail growth. As the FDA reported in a safety communication in 2017, the agency is aware of people taking high levels of biotin that may cause interference with lab tests. Many diagnostic tests use biotin technology due to its ability to bind to specific proteins, which can be measured to detect certain health conditions. For example, biotin is used in hormone tests and tests for markers of cardiac health like troponin.
Many dietary supplements promoted for hair, skin, and nail benefits contain biotin levels up to 650 times the recommended daily intake of biotin. Physicians may also be recommending high levels of biotin for patients with certain conditions such as multiple sclerosis. Biotin in blood or other samples taken from patients who are ingesting high levels of biotin in dietary supplements can cause clinically significant incorrect lab test results such as falsely high or falsely low results, depending on the test.
While the 2017 safety communication provides recommendations for patients, healthcare professionals and laboratory personnel to mitigate potential biotin interference, the draft guidance provides additional recommendations to in vitro diagnostic device manufacturers for testing for biotin interference on in vitro diagnostic devices that use biotin technology and communicating the results of such testing to the end-users.
The FDA will continue its work with stakeholders to better understand biotin interference with laboratory tests, including working with manufacturers as they address this issue in designing and developing tests that use biotin technology. The FDA will continue to monitor adverse event reports and will update the public if significant new information becomes available.
