FDA Issues Draft Guidance on Vitamin B7 Testing in IVDs

The FDA released draft guidance on testing for biotin (vitamin B7) interference in in vitro diagnostics and devices used in donor screening.

The agency said it has become aware of potential biotin interference with IVDs that use biotin/avidin interactions as part of the device technology. Biotin in patient samples can cause falsely high or falsely low results, depending on the test.

The draft spells out how the agency would like the testing be performed and how the results of the testing should be communicated to end users, including clinical laboratories and clinicians. The agency wants manufacturers of currently marketed devices to consider the recommendations.