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Diazyme Gets FDA Emergency Use Authorization for SARS-CoV-2 Antibody Test

NEW YORK — The US Food and Drug Administration this week granted Emergency Use Authorization to Diazyme Laboratories for a SARS-CoV-2 total antibody test.

The Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit is a fully automated chemiluminescent immunoassay designed for the qualitative direct detection of total neutralizing antibodies against SARS-CoV-2 in human serum and plasma. It is authorized as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. It runs on the company's DZ-lite 3000 Plus CLIA Analyzer.

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

In mid-2020, Poway, California-based Diazyme received EUA from the FDA for its Diazyme DZ-Lite SARS-CoV-2 IgG antibody test.