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FDA warns against using unapproved COVID-19 tests because of a 'high risk of false results'

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The Food and Drug Administration is warning consumers to stop using a specific brand of COVID-19 tests, claiming there is a high chance they will produce false results.

In a statement, the agency is urging people to stop using the LuSys Laboratories COVID-19 Antigen Test and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test.

The FDA said the tests may be sold under company names Luscient Diagnostics or Vivera Pharmaceuticals, or the trade name EagleDx.

"The performance of these tests has not been adequately established and the FDA believes there is likely a high risk of false results when using these tests," the FDA said in its statement.

People who used the tests are advised to contact their health care providers. Health professionals are advised to consider retesting if they suspect an inaccurate result.

How can you make sure the at-home kit you purchased is legitimate? Here are some tips, according to the Federal Trade Commission.

♦ Confirm it's FDA verified. Double-check the agency has authorized the test before you buy. The FDA features lists of approved tests on its website.

♦ Research the seller first. The FTC says if you don't know the seller, search their name with words like "scam" or "complaint" to check whether you get a lot of results suggesting the company is connected to any scams.

♦ Look for online reviews. Research the test kit on multiple websites to study reviews from other users. If you spot several negative reviews, it's likely a sign the test kit isn't legitimate. ...

 

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