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FDA Grants Emergency Use Authorizations for Coronavirus Antibody Tests From Vibrant America, Biotest Biotech

NEW YORK — The US Food and Drug Administration on Thursday granted separate Emergency Use Authorizations for antibody-based SARS-CoV-2 tests developed by Vibrant America and Biotest Biotech.

The Vibrant COVID-19 Ab assay is a chemiluminescence immunoassay designed for the qualitative detection and differentiation of immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against SARS-CoV-2 in serum or dry blood spots from finger pricks. The assay uses Hamilton Company's Microlab STAR liquid handling system and may only be performed at San Carlo, California-based Vibrant's CLIA-certified laboratory.

Biotest's RightSign COVID-19 IgG/IgM Rapid Test Cassette is designed to detect and differentiate IgM and IgG antibodies against SARS-CoV-2 in serum, plasma, and venous whole blood. Results are available in 10 minutes, according to the Hangzhou, China-based company. The test may be performed by any lab CLIA-certified to perform moderate- or high-complexity tests.