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Biotin (vitamin B7) may interfere with lab tests. The FDA is alerting 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 in blood or other samples taken from patients who are ingesting high levels of biotin in dietary supplements can cause clinically significant incorrect lab test results. The FDA has seen an increase in the number of reported adverse events, including one death, related to biotin interference with lab tests.

Biotin in patient samples can cause falsely high or falsely low results, depending on the test. For example, a falsely low result for troponin, a clinically important biomarker to aid in the diagnosis of heart attacks, may lead to a missed diagnosis and potentially serious clinical implications. The FDA has received a report that one patient taking high levels of biotin died following falsely low troponin test results when a troponin test known to have biotin interference was used.

The FDA is aware of people taking high levels of biotin that would interfere with lab tests. Many dietary supplements promoted for hair, skin, and nails contain biotin levels up to 650 times the recommended daily intake of biotin. Physicians may also be recommending high levels of biotin for patients with certain conditions such as multiple sclerosis (MS).

Patients and physicians may be unaware of biotin interference in laboratory assays. Even physicians who are aware of this interference are likely unaware of whether patients are taking biotin, and how much. Since patients are unaware of biotin interference, patients may not report taking biotin supplements to their physicians, and may even be unaware they are taking biotin.

The FDA is working with stakeholders to better understand biotin interference with laboratory tests, and to develop additional future recommendations for safe testing in patients who have taken high levels of biotin when using lab tests that use biotin technology. The FDA is monitoring reports of adverse events associated with biotin interference with lab tests and will update the public if new information becomes available.

The FDA's recommendations and information for lab personnel includes:

* If you use assays with biotin technology, be aware that it is difficult to identify samples that contain biotin; therefore, it is important to communicate with healthcare providers and patients to prevent incorrect test results.

* If you are collecting samples in the lab, ask whether the patient is taking biotin.

* Educate healthcare providers about biotin interference with certain tests used in your lab.

* Consider that the recommended daily allowance (RDA) for biotin is 0.03 mg and that this biotin level does not typically cause significant interference. However, supplements containing high biotin levels, including those marketed for hair, skin, and nails, may contain up to 20 mg of biotin, and physicians may recommend up to 300 mg per day for conditions such as MS. Biotin levels higher than the RDA may cause significant interference with affected lab tests.

* Specimens collected from patients taking high levels of biotin may contain more than 100 ng/mL biotin. Concentrations of biotin up to 1200 ng/mL may be present in specimens collected from patients taking up to 300 mg per day.

* Currently available data is insufficient to support recommendations for safe testing using affected tests in patients taking high levels of biotin, including about the length of time for biotin clearance from the blood.

* Communicate with the lab test manufacturer if you have questions about biotin interference.
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Title Annotation:The Observatory: NEWS * TRENDS * ANALYSIS
Publication:Medical Laboratory Observer
Geographic Code:1USA
Date:Jan 1, 2018
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