The ViroKey SARS-CoV-2 RT-PCR Test v2.0 is a real-time reverse transcription polymerase chain reaction (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.

CE-IVD: For in vitro diagnostic use. Not for distribution in U.S.

Reliable Detection:

• Sensitive and Robust
• Specific to SARS-CoV-2 RNA with no cross-reactivity
• Able to detect B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), B.1.617.2 (Delta), B.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), and C.37 (Lambda) strains.

Providing Laboratory Efficiency:

• Samples to results in 4 hours
• Hands-on time as short as 30 minutes
• Automation from sample to report with automated PCR result analysis
• Test up to 46 samples (plus two controls) per automated run

Increasing Cost Effectiveness:

• Two targets combined in one test to save reagent and consumable costs
• Comprehensive and fast result call-out to reduce patient management cost