FDA grants EUA for Diabetomics' SARS-CoV-2 Ab test

LabPulse.com staff writers
Jun 23, 2021
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Diabetomics announced the U.S. Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) for its CovAb SARS-CoV-2 Ab point-of-care test.

The CovAb test only requires an oral fluid sample obtained with a simple swab of the gumline, making it easy and painless, the company said in a statement. The test is CLIA-waived, is all-inclusive, and does not require any additional components or instrumentation, Diabetomics said. Test results reportedly are available within 15 minutes.

In addition, the CovAb test has a sensitivity of 97.6% and a specificity of 98.8%, Diabetomics reported.

The CovAb test was developed and manufactured in the U.S. and has received the CE Mark.

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