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InBios International Gets FDA Emergency Use Authorization for SARS-CoV-2 Total Antibody Test

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for InBios International's SCoV-2 Detect Neutralizing Ab ELISA immunoassay for SARS-CoV-2.

The enzyme-linked immunosorbent assay is designed for the qualitative direct detection of total neutralizing antibodies to SARS-CoV-2 in serum and plasma in order to identify individuals who have had a recent or prior infection. It may be used only by labs CLIA-certified to perform high-complexity tests, according to the FDA.

Seattle-based InBios has received EUA for a number of other SARS-CoV-2 assays including a point-of-care antibody test and a point-of-care antigen test.