The U.S. Food and Drug Administration (FDA) published draft guidance on June 13 that sets new standards regarding interference from vitamin B7, also called biotin, in IVD tests. Biotin technology is used in many medical diagnostic products, including hormone and troponin testing.
The draft guidance is an update from 2017. The agency previously advised the "public, [healthcare] providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected."
Biotin binds with certain proteins, and devices that utilize this interaction historically have been tested for interference from dietary biotin at normal recommended daily doses, according to the agency. However, increased levels of dietary biotin have led to unexpected reports of interference in some IVD devices.
