The Food and Drug Administration (FDA) has issued an updated safety communication reminding healthcare professionals about the possibility of biotin interference with certain lab tests.
Specifically, the Agency is concerned with reports of biotin interference causing falsely low cardiac troponin levels that could potentially lead to a missed diagnosis; cardiac troponin testing is an important component of the diagnostic workup for myocardial infarction. While some lab test developers have worked to reduce the risk of biotin interference since the 2017 announcement, some have yet to address the issue. As such, the FDA is providing healthcare professionals with a list of troponin in vitro diagnostic devices that are still subject to biotin interference.
In addition, the Agency continues to recommend the following:
- Talk to patients about any biotin supplements they may be taking
- Be aware that certain lab tests use biotin technology (ie, cardiovascular diagnostic tests, hormone tests) and that results may be potentially affected if there is biotin in the patient’s specimen
- Let the lab conducting the test know that the patient is taking biotin
- Consider biotin interference as a possible error if the test results do not match with clinical presentation
- Report adverse events following potentially incorrect lab test results due to biotin interference to the lab test manufacturer and the FDA
Biotin (vitamin B7), a water-soluble vitamin, is often found in multivitamins, prenatal vitamins, and dietary supplements. As many lab tests use biotin technology due its ability to bond with specific proteins, ingesting high levels of biotin can cause clinically significant incorrect lab results.
For more information visit fda.gov.