The U.S. Food and Drug Administration has granted Cellex an emergency use authorization to market a rapid antibody test for COVID-19, the first antibody test released amidst the pandemic."It is reasonable to believe that your product may be effective in diagnosing COVID-19," and "there is no adequate, approved, and available alternative," the agency said in a letter to Cellex. A drop of serum, plasma, or whole blood is placed into a well on a small cartridge, and the results are read 15-20 minutes later; lines indicate the presence of IgM, IgG, or both antibodies against the SARS-CoV-2 virus.
Of 128 samples confirmed positive by a reverse transcription-polymerase chain reaction in premarket testing, 120 tested positive by IgG, IgM, or both. Of 250 confirmed negative, 239 were negative by the rapid test. The numbers translated to a positive percent agreement with RT-PCR of 93.8% (95% CI:…
