
Viral Hepatitis Surveillance and Case Management
Feb 1, 2019

*Ingestion of high levels of biotin can significantly interfere with certain commonly used biotinylated immunoassays, such as those used to detect anti-HAV, and cause false-positive or false-negative laboratory test results. Currently, the US Food and Drug Administration (FDA) is investigating thresholds associated with false-positive and false-negative tests. This section will be updated as more information becomes available.
References
U.S. Food and Drug Administration. (2019). Update: The FDA warns that biotin may interfere with lab tests (FDA Safety Communication).
https://www.fda.gov/medical-devices/safety-communications/update-fda-warns-biotin-may-interfere-lab-tests-fda-safety-communication