The TaqPath™ COVID-19 Combo assay is an in vitro real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate swabs, nasopharyngeal aspirates, and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider. Results are for the identifications of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper respiratory and BAL 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 bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories in the United States and its territories are required to report all test 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.
Invalid results or inconclusive test results warrant repeat testing and clinical correlation, especially if COVID-19 exposure is suspected.
The TaqPath™ COVID-19 Combo assay has been authorized by the FDA under an Emergency Use Authorization (EUA) for use in authorized laboratories – laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meets requirements to perform high complexity tests.
All patient management decisions should be based on clinical judgment of a qualified health care professional.
These results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.