Release date: 2018-02-12
ã€introduction】
November 2017, the US Food and Drug Administration (FDA) announced recently received an interference caused due biotinylated troponin no cause of death in patients accurately reported, to remind clinicians and laboratory workers: high-dose supplements Biotin may cause errors in laboratory test results, causing clinical misdiagnosis and mistreatment.
Not long ago, the international top medical journal, New England Journal of Medicine, also published a number of misdiagnosis cases about biotin interference. With the emergence of more and more cases of misdiagnosis and mistreatment in the world, the interference of biotin on immune detection has become a hot topic in the near future.
[Clinicians need to understand and value the interference of biotin on clinical testing]
In this regard, Professor Xu Juntang from the Department of Cardiology of Peking University People's Hospital said: "Reliable laboratory test results are the key to clinically correct diagnosis of diseases. As an important marker and clinical basis of myocardial injury, troponin plays an important role in the diagnosis of acute myocardial infarction. Role. The FDA's case of biotin-induced pseudo-reduction of troponin has also caught the attention of our clinicians." He said that clinicians should fully understand laboratory testing methods and ask patients to supplement biotin in their treatment. For the case of some patients who take biotin for a long time, if the test results are inconsistent with the clinical results, the clinical judgment shall prevail and the corresponding diagnosis and treatment shall be carried out to avoid missed diagnosis, missed treatment and serious consequences, and the remedies shall be discussed with the laboratory personnel. Re-determination of troponin, such as without the use of a biotin labeling detection system.
[Application of biotin]
Biotin is a water-soluble B vitamin that is involved in cell metabolism and maintains normal cellular functions. It is widely added to various multivitamins, prenatal vitamins and commercially available nutritional supplements for hair, skin and nail growth. . With the increasing awareness of health and beauty in modern people, more and more people are taking exogenous biotin health products in order to achieve various purposes such as strengthening physical fitness, preventing hair loss, and losing weight and beauty. More notably, many people are not aware of taking biotin because of the complexity of the ingredients and the diversity of names.
Biotin OTC health care products recommended doses of 5mg-10mg, studies have shown that daily intake of biotin 10mg, for 7 days, the concentration of biotin detected in circulating blood can exceed 3000pg / ml, this concentration can affect multiple Laboratory testing 4.
[Important biotin interference and strengthen related research]
In the field of laboratory immunoassays, the application of biotin has become very common. The "Biotin-Streptavidin" system is a biological reaction amplification system developed in the late 1970s. The methodology based on the "Biotin-Streptavidin" system can amplify detection signals specifically and efficiently, and improve the sensitivity of immunoassays. Many immunoassay products on the market use this methodology. When using this type of test product, a high concentration of free biotin in the blood may interfere with the ability of streptavidin to capture the analyte of interest if the patient takes exogenous biotin. Biotin can cause a false increase or decrease in the test results due to differences in methodology. The laboratory's inspection professionals need to understand the detection principle of the detection platform in this laboratory, identify the detection items that are interfered by exogenous biotin, and communicate with the clinic in time to ensure the correctness of the test results.
Director Yuan Hui of the Department of Clinical Laboratory of Anzhen Hospital, Capital Medical University, said: "The interference of biotin on immunoassay has gradually attracted the attention of foreign clinical examiners in recent years, and in the famous medical academic journal "New England Journal of Medicine" and " There are case sharing in JAMA. In China, there are still few reports. However, our understanding of how biotin interferes with clinical testing is still the tip of the iceberg. The dosage of biotin, the time of taking it, and the type of project affected. Etc. Further systematic research evaluation is needed."
ã€to sum up】
FDA Recommendation 5: “If laboratory test results do not match the patient's clinical performance, biotin interference should be considered as a possible cause.†In clinical practice, many patients may be limited by their expertise and simply do not know if they are taking the organism. It is ignorant of the possible interference of biotin. When test results and clinical non-conformities occur, laboratory professionals are required to assess the risks that may exist in the laboratory at the first time and strengthen communication with the clinic. Clinicians should increase their professional knowledge and understanding of the test, and should not ignore it because they are ignorant, thus affecting the judgment and diagnosis of the disease. The risk of biotin interference should be highly valued by both clinical and laboratory tests. By combining clinical and testing, we provide patients with better services.
1. Biotin (Vitamin B7): Safety Communication - May Interfere with Lab Tests - From FDA website https://
2. Biotin Treatment Mimicking Graves' Disease. N Engl J Med. 2016;375:7
3. Biotin: From Nutrition to Therapeutics. J Nutr. 2017;147(8):1487-1492
4. Association of Biotin Ingestion With Performance of Hormone and Nonhormone Assays in Healthy Adults. JAMA. 2017;318(12):1150-1160
5. 医脉通 compiled from: Michael O'Riordan. Biotin Supplements Can Interfere With Cardiac Troponin Tests: FDA. TCTMD. November 28, 2017
Source: Bio Valley
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