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FDA Grants Emergency Use Authorizations to DiaSorin, NanoEntek, Nirmidas Coronavirus Antibody Tests

NEW YORK — The US Food and Drug Administration on Tuesday granted separate Emergency Use Authorizations for SARS-CoV-2 antibody tests developed by DiaSorin, NanoEntek America, and Nirmidas Biotech.

DiaSorin's Liaison SARS-CoV-2 IgM Assay is an indirect chemiluminescent immunoassay designed to detect immunoglobulin M (IgM) antibodies against the virus in serum and plasma. It runs on the Saluggia, Italy-based company's Liaison XL Analyzer.

In April, DiaSorin received EUA from the FDA for a serology assay that identifies the presence of immunoglobulin G (IgG) antibodies against SARS-CoV-2.

NanoEntek's Frend COVID-19 total Ab is a cartridge-based fluorescence immunoassay that detects IgM and IgG antibodies against SARS-CoV-2 in plasma. It runs on the South Korean company's point-of-care Frend System.

The Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit is a single-use lateral flow immunoassay designed to detect and differentiate IgM and IgG antibodies against SARS-CoV-2 in serum and plasma. Results are read on a test card within 15 minutes, according to the Palo Alto, California-based company.

All three tests may be used by any laboratory CLIA-certified to perform moderate- or high-complexity tests, the FDA said.