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NEW YORK — The US Food and Drug Administration on Wednesday granted Emergency Use Authorization for a SARS-CoV-2 rapid antibody test developed by Jiangsu Well Biotech.

The Orawell IgM/IgG Rapid Test is a lateral flow immunoassay designed to detect and differentiate immunoglobulin M and G antibodies against SARS-CoV-2 in human serum and plasma. Results are available in 10 minutes, according to the Jiangsu, China-based company.

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

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