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FDA Grants Emergency Use Authorization for Acon Laboratories Coronavirus Antibody Test

NEW YORK — The US Food and Drug Administration on Tuesday granted Emergency Use Authorization for a SARS-CoV-2 antibody test developed by Acon Laboratories.

The ACON SARS-CoV-2 IgG/IgM Rapid Test is designed for the detection and differentiation of immunoglobulin M and G against SARS-CoV-2 in serum, plasma, and whole blood. The lateral flow chromatographic immunoassay provides results within 20 minutes, according to San Diego-based Acon.

The test may be used by any lab CLIA-certified to perform moderate- or high-complexity tests, the FDA said.