Accuracy concerns arise after FDA allows COVID-19 antibody tests to be sold without authorization

FDA allowing antibody tests to be sold without approval
FDA allowing antibody tests to be sold without approval

DETROIT – There are concerns about the accuracy of antibody tests that would help determine if someone had and recovered from coronavirus (COVID-19).

The Food and Drug Administration has granted emergency use authorizations to four antibody tests. Tests from Cellex, Ortho Clinical Diagnostics, ChemBio Diagnostics and Mount Sinai Health System are the only ones authorized.

However, the administration is also allowing about 90 companies to sell antibody tests without authorization or review. These companies are expected to self-validate the tests to ensure they are accurate.

According to Sean Tabibian’s diagnostic lab, 70 percent of tests from five different companies that do not have FDA approval provided inconsistent results.

“These rapid test kits are dangerous,” he said. “They’re giving false positives or negatives. It might give people a false sense of security that they somehow have immunity.”

A Texas health department also had similar results. One brand of test kits it tried was only 20 percent reliable. The company claimed up to 97 percent accuracy.

The FDA is working with the Centers for Disease Control and Prevention to help validate some tests and make them more accurate.

MORE: What the CDC says you should do if you believe you have coronavirus (COVID-19)


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