SARS-CoV-2, NAA (PCR)

Amplification of target nucleic acids are performed using forward and reverse primers specifically designed for the ORF1, a region unique to SARS-CoV-2. A conserved region in the structural protein envelope E-gene was selected for the detection for pan-Sarbecovirus which will detect SARS-CoV-2. Selective amplification of the RNA internal control is performed using specific primers with no homology with the coronavirus genome.

This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization (EUA). This test is only authorized for the duration of time the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of SARS-CoV-2 virus and/or diagnosis of COVID-19 infection under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of a patient's recent exposures and the presence of clinical signs and symptoms consistent with COVID-19. An individual without symptoms of COVID-19 and who is not shedding SARS-CoV-2 virus would expect to have a negative (not detected) result in this assay. For more information please see below:

Fact Sheet for Healthcare Providers: https://www.fda.gov/media/136047/download

Fact Sheet for Patients: https://www.fda.gov/media/136048/download