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FDA Grants EUAs for Coronavirus Tests From Grifols, Visby Medical, Immunodiagnostic Systems

NEW YORK — The US Food and Drug Administration last week granted separate Emergency Use Authorizations for molecular SARS-CoV-2 tests from Grifols Diagnostic Solutions, Visby Medical, and Immunodiagnostic Systems.

Grifols' Procleix SARS-CoV-2 Assay uses transcription-mediated nucleic acid amplification to detect SARS-CoV-2 nucleic acid in anterior nasal, mid-turbinate nasal, nasopharyngeal, and oropharyngeal swab specimens, as well as nasopharyngeal washes/aspirates, nasal aspirates, and bronchoalveolar lavage. The test runs on the San Diego-based company's fully automated Procleix Panther System, which integrates processing, interpretation, and management of nucleic acid testing.

The assay may be used by any lab CLIA-certified to perform high-complexity tests, according to the FDA.

The Visby Medical COVID-19 Point of Care Test is a single-use, fully integrated RT-PCR assay designed to detect SARS-CoV-2 nucleic acid in nasopharyngeal, anterior nasal, or mid-turbinate swabs collected by a health care provider or in anterior nasal or mid-turbinate swabs self-collected under the supervision of a healthcare provider. Results are provided within 30 minutes after a sample is loaded into the testing device.

The assay may be used by labs CLIA-certified to perform high-, moderate-, or waived-complexity tests, as well as at the point of care in settings operating under a CLIA A Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Earlier this month, San Jose, California-based Visby won a $12.3 million contract from the US Department of Health and Human Services to develop a combination SARS-CoV-2/influenza test.

UK-based Immunodiagnostic Systems' IDS SARS-CoV-2 IgG is an automated chemiluminescent immunoassay designed to detect immunoglobulin G against SARS-CoV-2 in serum and plasma.

It may be used by any lab CLIA-certified to perform moderate- or high-complexity tests.

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