NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization to InBios International for its point-of-care SCoV-2 Detect IgG Rapid Test for antibodies against SARS-CoV-2.
The lateral flow chromatographic immunoassay is designed to detect immunoglobulin G against the virus in serum, plasma, and whole blood, as well as in fingerstick blood samples.
The test may only be used by labs CLIA-certified to perform moderate- or high-complexity tests when using serum, plasma, or whole-blood samples. With fingerstick blood samples, the test may be used by labs CLIA-certified to perform high-, moderate-, or waived-complexity tests, or in point-of-care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Earlier this year, Seattle-based InBios received EUA from the FDA for a point-of-care SARS-CoV-2 antigen test.