Skip to main content
Premium Trial:

Request an Annual Quote

FDA Grants Emergency Use Authorization for Jiangsu Well Biotech Coronavirus Antibody Test

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.