Only IgG assay from top four in vitro diagnostic manufacturers that detects antibodies targeting the receptor binding domain on the spike protein
Company able to deliver 30 million tests per month, and now available in all countries accepting FDA EUA and CE Mark
Serology test has confirmed 100% sensitivity and 99.6% specificity
BREA, Calif., June 29, 2020 /PRNewswire/ -- Beckman Coulter today announced that its Access SARS-CoV-2 IgG assay has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA). Beckman Coulter has already shipped tests to more than 400 hospitals, clinics and diagnostics laboratories in the U.S., and has begun distribution of the new antibody test globally to countries that accept the FDA EUA and CE Mark. The company is able to deliver more than 30 million tests a month.