Severe acute respiratory syndrome-associated coronavirus IVDs

Intended purpose

The ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 is a real-time RT-PCR based in vitro diagnostic test intended for the qualitative detection of RNA from SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs from individuals suspected of COVID-19 by their healthcare provider. The ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 is configured for use on the Sentosa® SX101 instrument, with the ViroKey™ SX Virus Total Nucleic Acid Kit or the Sentosa® SX Virus Total Nucleic Acid Kit v2.0, in conjunction with Sentosa® SA201 Real-Time PCR system or the Applied Biosystems® 7500 Fast Dx Real-Time PCR system. Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in nasopharyngeal and oropharyngeal swabs 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. 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.