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BioMérieux SARS-CoV-2 Serology Tests Granted FDA Emergency Use Authorization

By LabMedica International staff writers
Posted on 11 Aug 2020
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BioMérieux’s (Marcy-l'Étoile, France) has been granted Emergency Use Authorizations (EUAs) by the US Food and Drug Administration (FDA) for two SARS-CoV-2 serology tests.

The FDA has granted EUA to BioMérieux’s VIDAS SARS-COV-2 IgM and VIDAS SARS-COV-2 IgG automated qualitative assays which rapidly detect antibodies to help identify individuals with previous exposure to SARS-CoV-2. With the same protocols to differentiate IgM and IgG results, the VIDAS SARS-COV-2 IgM detects IgM specific for SARS-CoV-2 while the VIDAS SARS-COV-2 IgG detects IgG specific for SARS-CoV-2.

Both the assays use a two-step sandwich enzyme immunoassay method with final fluorescence detection (ELFA). Available on-demand 24/7 on all VIDAS platforms, they offer flexibility and reliability for results in less than 30 minutes. All the assay steps are performed automatically by the instrument which is intuitive and easy to use with limited maintenance, calibration and controls. Both the assays deliver a performance with high specificity and sensitivity from day eight and generate results that help provide additional pandemic analysis data. According to the FDA, both the tests can be used by any lab CLIA-certified to perform moderate- or high-complexity testing.

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