The FDA authorization process can be an unwieldy one, but it’s necessary to ensure that all medical products on the market are safe, effective and consistent in quality.
That’s why the agency continues to crack down on the sale of unauthorized COVID-19 diagnostics, citing in a recent safety notice the “potentially higher risk of false results” that comes with using tests that haven’t yet met the agency’s safety standards.The target of that Jan. 28 notice was Empowered Diagnostics, a Florida-based testmaker that has recalled hundreds of thousands of rapid antigen and antibody tests for the coronavirus that were sold in the U.S. without the FDA’s sign-off.
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The recall was initiated at the end of December and given a Class I rating—the FDA’s most serious—last week. It comprises at least 284,575 CovClear rapid antigen tests and 2,100 ImmunoPass rapid antibody tests that were distributed between Jan. 1 and Nov. 11 of last year.
The CovClear diagnostic analyzes a nasal swab to detect an active case of COVID within 20 minutes. The test has been authorized in Canada and the E.U. for at-home and point-of-care use, respectively, and boasts a sensitivity rate of 95.5% and 100% specificity, according to Empowered.
The ImmunoPass test, meanwhile, requires a fingerstick blood sample to determine whether antibodies are present from a previous case of the virus. It returns results in 10 minutes and offers a sensitivity rate of 94%, plus 97% specificity. Empowered doesn’t list any regional authorizations for ImmunoPass on its website, but notes that neither it nor the CovClear test is available for sale or distribution in the U.S.
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No injuries or deaths have been reported in relation to the recalled tests, but the FDA warned that both false-positive and false-negative results from either diagnostic could have serious consequences. False positives, for example, could lull test-takers into a false sense of security, leading them to loosen precautions after they believe the infection has passed, while false negatives could lead to further spread of the virus.
In its safety notice, the FDA recommended that those who took a CovClear antigen test in the last two weeks be retested with another diagnostic that has been OK’d by the agency. If the test was taken more than two weeks ago and the test taker isn’t believed to have a current infection, however, they don’t need to be tested again.
In the case of the antibody test, the FDA said that anyone who used an ImmunoPass kit and suspects that it returned a false result may want to consider taking another antibody test.
Any issues with either test should be reported to the FDA. Customers can also contact Empowered for instructions about disposing any unused tests and requesting refunds. In the meantime, the FDA said it is “working with Empowered Diagnostics to resolve these issues” and will continue to update the public with any “significant new information” about the recall as it arises.