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COVID-19 tests and biotin | What you need to know

The FDA requires companies conduct extra testing and label COVID-19 tests if there's a chance high doses of biotin could impact results.

ATLANTA — Want healthy hair? Stronger nails? Then, you may have considered using biotin. Yet, recent social media posts raise concerns that taking too much could lead to a false negative on a COVID-19 test.

Biotin, or vitamin B7, is found naturally in some foods, yet there are also supplements available marketed for hair, skin and nail growth, which have recently become popular. But according to the FDA, some dietary supplements contain biotin levels up to 650 times the recommended daily amount.

"Even though the medical experts suggest taking a pretty small amount of biotin to kind of maintain the levels that you need for your body to function well, some people take thousands of times that amount," Dr. Gigi Gronvall, a Senior Scholar at the Johns Hopkins Center for Health Security and an associate professor at the Johns Hopkins Bloomberg School, explained. "So that can be a problem for some kinds of tests, some kinds of blood tests in particular, that use biotin as part of the mechanism of the test."

Because biotin bonds with specific proteins, it's sometimes used within the actual testing process as a marker, helping to detect certain health conditions. 

In 2019, the FDA issued a warning about potential biotin interference for certain types of blood tests, particularly tests for troponin, a clinically important biomarker to aid in the diagnosis of heart attack.

Yet, a spokesperson for the agency said the agency "is not aware of any issues with biotin interference with COVID tests and has not received any medical device reports regarding biotin impacting results of COVID-19 tests."

According to the statement, "while there is a theoretical potential for interference, it is unlikely that there would be substantial amounts of biotin in mucus/nasal samples. The non-COVID tests for which we have seen biotin interference are blood tests."

A spokesperson did confirm, however, that FDA guidelines required COVID-19 test manufacturers to conduct biotin interference testing should their tests use a biotin/anti-biotin capture system. If there's a chance for interference, specific labeling is also required in the instructions for use. 

11Alive learned of at least three test kits that disclose taking high doses of biotin could lead to a false negative result. 

The majority of COVID-19 tests, though, do not report that limitation. Dr. Gronvall emphasized that most rapid antigen tests do not use the biotin-based technology but users taking high doses of biotin should be aware  

"I think you know this is just something that you need to tell your pharmacist and to double check," she advised. "In general, people need to be aware of the kinds of non-prescribed things that they're taking and how that could affect medications, how it could affect tests."

"In this case, a false negative gives people a false sense of security," she added. 

So when should you be concerned?

"Probably, this requires a really high level of ingesting biotin to be a problem," Dr. M.G. Finn with the Georgia Institute of Technology explained. "So a normal multivitamin won't have anywhere near that amount of that supplement in it so you don't have to worry there."

Both Finn and Gronvall emphasize that COVID-19 tests are only part of the equation when it comes to diagnosing positive cases, saying the tests are a tool but not perfect. 

"People should be using them, but really with respect to COVID being primarily guided by their symptoms," he said. "If you feel sick, it's likely that you are infected."

The three tests 11Alive found which indicate a possibility of biotin interference are found below. 11Alive reached out to all three companies for comment but has not yet received a response: 

DetectTM Covid-19 Test
iHealth® COVID-19 Antigen Rapid Test Pro
CareStart™ COVID-19 Antigen Home Test

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