Biotin (Vitamin B7): Safety Communication - May Interfere with Lab Tests（續上期）
BACKGROUND: Many lab tests use biotin technology due to its ability to bond with specific proteins which can be measured to detect certain health conditions. For example, biotin is used in hormone tests and tests for markers of cardiac health like troponin. Biotin, also known as vitamin B7, is a water-soluble vitamin often found in multi-vitamins, prenatal vitamins, and dietary supplements marketed for hair, skin, and nail growth.
For Health Care Providers:
• Talk to your patients about any biotin supplements they may be taking, including supplements marketed for hair, skin, and nail growth.
• Be aware that many lab tests, including but not limited to cardiovascular diagnostic tests and hormone tests, that use biotin technology are potentially affected, and incorrect test results may be generated if there is biotin in the patient's specimen.
• Communicate to the lab conducting the testing if your patient is taking biotin.
• If a lab test result doesn't match the clinical presentation of your patient, consider biotin interference as a possible source of error.
• Know that biotin is found in multivitamins, including prenatal multivitamins, biotin supplements, and dietary supplements for hair, skin, and nail growth in levels that may interfere with lab tests.
• Report to the lab test manufacturer and the FDA if you become aware of a patient experiencing an adverse event following potentially incorrect laboratory test results due to biotin interference.
For Lab Personnel:
• 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 health care providers and patients to prevent incorrect test results.
• If you are collecting samples in the lab, ask whether the patient is taking biotin.
• Educate health care providers about biotin interference with certain lab tests used in your lab.
• Consider that the daily recommended allowance for biotin is 0.03 mg and these biotin levels do not typically cause significant interference. However, supplements containing high biotin levels including those marketed for hair, skin, and nail benefits, may contain up to 20 mg of biotin, and physicians may recommend up to 300 mg per day for conditions such as multiple sclerosis. Biotin levels higher than the recommended daily allowance may cause significant interference with affected lab tests.
• Be aware that 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.
• Talk to your doctor if you are currently taking biotin or are considering adding biotin, or a supplement containing biotin, to your diet.
• Know that biotin is found in multivitamins, including prenatal multivitamins, biotin supplements, and supplements for hair, skin, and nail growth in levels that may interfere with laboratory tests.
• Be aware that some supplements, particularly those labeled for hair, skin, and nail benefits, may have high levels of biotin, which may not be clear from the name of the supplement.
• If you have had a lab test done and are concerned about the results, talk to your health care provider about the possibility of biotin interference.
Read the MedWatch Safety Alert, including a link to the FDA Safety Communication, at:
4. 每日建議補充之biotin含量為0.03 mg，此含量並不會顯著影響檢驗數值。然而標榜對頭髮、皮膚以及指甲有好處的之營養補充品，可能含超過20 mg之biotin，或醫師可能會建議多發性硬化症之病人每日服用300 mg之biotin，遠高於每日建議補充量之biotin可能會顯著影響檢驗結果。
5. 使用高單位biotin之病人檢體，其內含biotin濃度可能超過100 ng/mL，每日服用300 mg之biotin，其檢體含biotin之濃度更高達1200 ng/mL。