CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
April 3, 2020—Cellex has received FDA emergency use authorization for its Cellex qSARS-CoV-2 IgG/IgM Rapid Test. The test is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in serum, plasma (EDTA or citrate), or venipuncture whole blood specimens from patients suspected of COVID-19 infection by a health care provider. Results are available in 15 to 20 minutes.