StrongStep® SARS-CoV-2 & Influenza A/B Multiplex Real-Time PCR Kit is intended for simultaneous qualitative detection and differentiation of SARS-CoV-2,Influenza A virus and Influenza B virus RNA in healthcare provider-collected nasal and nasopharyngeal swab or oropharyngeal swab specimens and self-collected nasal or oropharyngeal swab specimens(collected in a healthcare setting with instruction by a healthcare provider) from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. RNA from SARS-CoV-2, influenza A, and influenza B is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2, influenza A, and/or influenza B 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. Negative results do not preclude infection from SARS-CoV-2, influenza A, and/or influenza B and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. StrongStep® SARS-CoV-2 & Influenza A/B Multiplex Real-Time PCR Kit is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR assays and in vitro diagnostic procedures.