Patient Safety and Healthcare Quality

Organization (Website) Origin: FDA (https://www.fda.gov)

Topic Brief:

The FDA has issued an updated safety communication which provides new information on biotin interference with certain troponin laboratory tests. For more information, refer to 'Biotin Interference with Certain Troponin Lab Tests' (link below) for details on specific tests.

FDA Update Issued: November 5, 2019
The U.S. Food and Drug Administration (FDA) is updating our 2017 safety communication to remind the public, health care providers, lab personnel, and lab test developers that biotin, often found in dietary supplements, can significantly interfere with certain lab tests and cause incorrect results that may go undetected. The FDA wants to make the public and health care providers aware about biotin interference with lab tests so that patients, physicians, and laboratories can work together to help prevent adverse events.
As noted in the original safety communication, while biotin in patient samples can cause falsely high or falsely low results, depending on the type of test, the FDA is particularly concerned about biotin interference causing a falsely low result for troponin, a clinically important biomarker to aid in the diagnosis of heart attacks, which may lead to a missed diagnosis and potentially serious clinical implications. The FDA continues to receive adverse events reports indicating biotin interference caused falsely low troponin results…..

Recommendations are given for consumers, health care providers, manufacturers and laboratory personnel.
FDA Update URL: https://www.fda.gov/medical-devices/safety-communications/update-fda-warns-biotin-may-interfere-lab-tests-fda-safety-communication

Biotin Interference Certain Troponin Tests URL: https://www.fda.gov/medical-devices/vitro-diagnostics/biotin-interference-troponin-lab-tests-assays-subject-biotin-interference

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Lezlee Koch, ASCLS Patient Safety Committee
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