Life Sciences Insight

DiaSorin Gets FDA Emergency Use Authorization for Coronavirus Antigen Test

The US Food and Drug Administration last month granted Emergency Use Authorization for DiaSorin’s Liaison SARS-CoV-2 Ag SARS-CoV-2 antigen test.

The chemiluminescent immunoassay is designed to detect SARS-CoV-2 nucleocapsid protein antigen in nasopharyngeal swab samples collected by healthcare providers using Copan Diagnostics’ universal transport media and direct anterior nasal swab collected without transport media.

The test runs on DiaSorin’s Liaison XL Analyzer and may be used by any lab CLIA-certified to perform moderate- or high-complexity tests, according to the FDA.

In January, Saluggia, Italy‎-based DiaSorin received new funding from the US Department of Health and Human Services to develop molecular SARS-CoV-2 tests.

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