FDA

Abbott’s POC Test to Diagnose COVID-19 May Be Inaccurate, FDA Issues Alert

By MedTech Intelligence Staff
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FDA

The Abbott ID NOW test may return false negative results.

Yesterday FDA issued a public alert concerning the inaccuracy of the Abbott ID NOW point-of-care test used to diagnose COVID-19. The agency has received 15 adverse event reports, which indicates that the test may return false negative results.

“We will continue to study the data available and are working with the company to create additional mechanisms for studying the test. This test can still be used and can correctly identify many positive cases in minutes. Negative results may need to be confirmed with a high-sensitivity authorized molecular test,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in CDRH in an agency news release. He added that FDA is in direct communication with Abbott about the issue. Abbott will be conducting postmarket studies for the ID NOW test, the results of which will be used by FDA to assess whether there are patterns related to the accuracy issues.

FDA also referred to scientific studies that have called out accuracy issues of the Abbott ID NOW test. It is looking into whether the problem may be a result of the types of swabs being used or the viral transport media.

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