The COVID-19 RT-PCR Peptide Nucleic Acid (PNA) KIT is a real-time reverse transcription (RT)-Polymerase chain reaction (PCR) assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens such as nasopharyngeal swabs, oropharyngeal swabs, anterior nasal swabs, midturbinate nasal swabs, bronchoalveolar lavage (BAL), and nasopharyngeal wash/aspirates or nasal aspirates collected from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high complexity tests. Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out a bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The COVID-19 RT-PCR PNA KIT is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The COVID-19 RT-PCR PNA KIT is only for use under the Food and Drug Administrations Emergency Use Authorization.
