Industry Bulletins | April 8, 2020
FDA Grants Emergency Authorization For First Rapid Antibody Test For COVID-19
The U.S. Food and Drug Administration (FDA) has granted Cellex an emergency use authorization to market a rapid antibody test for COVID-19, the first antibody test released amidst the pandemic. A drop of serum, plasma, or whole blood is placed into a well on a small cartridge, and the results are read 15 to 20 minutes later; lines indicate the presence of IgM, IgG, or both antibodies against the SARS-CoV-2 virus.
Of 128 samples confirmed positive by reverse transcription polymerase chain reaction in premarket testing, 120 tested positive by IgG, IgM, or both. Of 250 confirmed . . .