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DiaSorin, Salofa Get FDA Emergency Use Authorization for SARS-CoV-2 Assays

NEW YORK — The US Food and Drug Administration last week granted separate Emergency Use Authorizations for SARS-CoV-2 assays developed by DiaSorin and Salofa.

DiaSorin's Liaison SARS-CoV-2 TrimericS IgG test is a chemiluminescent immunoassay designed to detect immunoglobulin G against the virus in serum and plasma. It runs on the Saluggia, Italy-based company's Liaison XL analyzer and is authorized for use by any lab CLIA-certified to perform high-complexity tests, according to the FDA.

Last month, DiaSorin, which recently reported a jump in first quarter revenues on sales of its coronavirus test offerings, received EUA from the FDA for its Liaison SARS-CoV-2 Ag SARS-CoV-2 antigen assay.

Salofa's Sienna-Clarity COVID-19 Antigen Rapid Test Cassette is a point-of-care rapid chromatographic assay designed to detect the SARS-CoV-2 nucleocapsid protein antigen in direct nasopharyngeal swab specimens. The test may be used by any lab CLIA-certified to perform moderate-, high-, or waived-complexity tests. It is also authorized for use in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation, the FDA said.

About a year ago, Salo, Finland-based Salofa received FDA EUA for a SARS-CoV-2 antibody assay.