FDA New Supplement Test: Know It Now!

FDA ( Food and Drug Administration) has lately renewed its 2017 security information to remind the public, wellness care providers, lab staff, and lab test developers that biotin, usually found in dietary complements, can vitally intervene with special lab tests and cause inaccurate results that may go undetected.

Biotin, also recognized as vitamin B7 or vitamin H, is a cofactor for five carboxylases (propionyl-CoA carboxylase, pyruvate carboxylase, methylcrotonyl-CoA carboxylase, acetyl-CoA carboxylase 1, and acetyl-CoA carboxylase 2) that catalyze significant steps in the metabolism of fatty acids, glucose, and amino acids. It is often promoted as a dietary supplement to grow hair and nails.

The regular suggested admission for an adult is 30 μg, but many biotin supplements contain much higher doses, ranging from 5,000 μg to 10,000 μg.

Lots of lab experiments, particularly those used to diagnose thyroid and heart illness, use biotin immunoassay technology and are probably affected by biotin in a patient’s blood sample.

FDA is especially concerned about biotin resistance causing falsely low returns when testing for cardiac troponin, a protein presents typically in minimal amounts in the blood, but for which blood levels develop during and after a cardiac event. The more damage to the heart, the higher the concentration of cardiac troponin in the blood.

Examination of cardiac troponin

It is said that use a streptavidin-biotin interaction step is typically practiced to test for cardiac troponin. In such assays, excess biotin could bind the streptavidin, blocking the binding of the cardiac troponin–antibody complexes.

This may direct to a wrongly low cardiac troponin result if the patient has a high level of plasma biotin, resulting in a missed diagnosis of myocardial injury, including myocardial infarction, due to the underestimation of cardiac troponin. Standard multivitamin levels of biotin (30–60 μg) pose no risk of interference with these tests.

According to FDA, some lab test developers have been successful at mitigating the biotin interference in their assays since the 2017 FDA safety communication, but others have not yet written it.

These manufacturers recommend a biotin washout period of several hours to weeks before sample selection to avoid biotin interference. But for time-sensitive tests, such as those for the increased levels of cardiac troponin that result from myocardial injury, a washout period is not feasible.

FDA has extended to receive adverse event reports indicating that biotin interference caused incorrectly low troponin results.

To improve transparency about this issue, the FDA produced a website to inform the public and health care providers about troponin assays that have not discussed the risk of biotin blocking. The site contains a table listing 17 cardiac troponin diagnostic tests that are subject to biotin interference but whose manufacturers have not addressed this risk.

How To Inform The Patients?

Sufferers will likely not report biotin additions to their doctor or pharmacist—and may not understand they are taking biotin, particularly when considering products labeled as beneficial for hair and nails. Even when biotin supplements are reported, neither cases nor physicians may be aware of biotin interference in laboratory immunoassays for cardiac troponin.

FDA suggests that health care providers talk to sufferers about any supplements or multivitamins they are taking that may contain biotin. Make sure patients understand that biotin is found in some fantastic products, especially those intended for hair, skin, and nails, in levels that may interfere with lab tests, and that they should report this biotin use to their physician before getting any recommended blood tests.