IEH SARS-CoV-2 RT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in in nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal aspirates, nasal washed and bronchoalveolar lavage (BAL) fluid from patients suspected of COVID-19 by their healthcare provider. Testing is limited to those certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories.
Results are for the identification of SARS-CoV-2 RNA. SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. The agent detected may not be the definite cause of disease. Positive results do not rule out bacterial infection or co-infection with other viruses. Laboratories within the United States and its territories are required to report all positive results to appropriate public health authorities.
Negative results do not preclude 2019-nCoV 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 IEH SARS-CoV-2 RT-PCR Test 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 IEH SARS-CoV-2 RT-PCR Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.