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FDA Grants Emergency Use Authorization for Innovita Biological Coronavirus Antibody Test

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization to a SARS-CoV-2 antibody test developed by Chinese biotechnology firm Innovita Biological Technology.

The Innovita 2019-nCoV Ab Test (Colloidal Gold) is a rapid lateral flow chromatographic immunoassay designed to detect immunoglobulin M and immunoglobulin G against SARS-CoV-2 in serum, plasma, and whole blood samples. Test results are provided within 10 to 15 minutes, according to Innovita.

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

Innovita is also developing a rapid, at-home SARS-CoV-2 serology test, which it exclusively licensed to Scanwell Health earlier this year.