SARS-CoV-2 by PCR

THIS IS A REAL-TIME PCR ASSAY FOR THE RAPID AND PRESUMPTIVE QUALITATIVE DETECTION OF RNA FROM SARS-COV-2 (ETIOLOGICAL CAUSE OF COVID-19). POSITIVE RESULTS ARE INDICATIVE OF ACTIVE INFECTION WITH SARS-COV-2, BUT DO NOT RULE OUT BACTERIAL INFECTION OR CO-INFECTION WITH OTHER VIRUSES. NEGATIVE RESULTS DO NOT PRECLUDE SARS-COV-2 INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR TREATMENT OR OTHER PATIENT MANAGEMENT DECISIONS.

The SARS-COV-2 by Polymerase Chain Reaction (PCR) or Transcription Mediated Amplification (TMA) assays (TaqPath COVID-19 Combo, Aptima SARS-CoV-2 or Panther Fusion SARS-CoV-2) have not been FDA cleared or approved, but have been authorized for emergency use by FDA under an EUA for use by authorized laboratories. The SARS-COV-2 by Polymerase Chain Reaction (PCR) or Transcription Mediated Amplification (TMA) assays (TaqPath COVID-19 Combo, Aptima SARS-CoV-2 or Panther Fusion SARS-CoV-2) have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens and the emergency use of the SARS-COV-2 by Polymerase Chain Reaction (PCR) or Transcription Mediated Amplification (TMA) assays (TaqPath COVID-19 Combo, Aptima SARS-CoV-2 or Panther Fusion SARS-CoV-2) are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. Section 360bbb-3(b)(1), unless the declaration is terminated or the authorization is revoked sooner.