Is this test authorized by the FDA?
Yes. The Alinity m SARS-CoV-2 Assay assay is authorized by the FDA under the Emergency Medical Use Authorization (EUA). The EUA for this test is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19. This EUA will remain in effect (meaning this assay can be used) for the duration of the COVID-19 declaration justifying the emergency of IVDs, unless it is terminated or revoked by FDA (after which the assay may no longer be used).
For more information, please refer to Alinity's FDA Emergency Use Authorization.