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

LabPulse.com staff writers
Jun 23, 2021
2020 01 21 22 13 2411 Virus Coronavirus 400

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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