The U.S. Food and Drug Administration (FDA) has granted the first emergency use authorization for a test to determine COVID-19 status from antibodies in blood samples to the biotechnology company Cellex.
The immunoglobulin G/immunoglobulin M (IgG/IgM) rapid test can detect antibodies against SARS-CoV-2 in serum, plasma, or venipuncture whole blood. Healthcare providers can use the test for individuals with suspected cases of COVID-19, the FDA noted in a letter to the company about the authorization.
To use the test, professionals first must allow the device cassette, specimen, and buffer solution to equilibrate to room temperature. A 10-µL specimen can then be transferred to the center of the sample well. Once the sample well is free of liquid, professionals add two sample diluent drops, and the results can be read 15 to 20 minutes later.
Cellex's headquarters are in Research Triangle Park, NC, and the company maintains an Asian base in Guangdong, China.
