The artus SARS-CoV-2 Prep&Amp UM Kit is a liquid-based approach to viral RNA detection. The kit is optimized for a simple sample preparation followed by qualitative real-time PCR detection of SARS-CoV-2 RNA in nasopharyngeal swabs (NPS), nasal swabs and oropharyngeal swabs from individuals with signs and symptoms of infection or who are suspected of COVID-19. Fewer and simpler workflow steps accelerate the turnaround time while decreasing hands-on time.
The artus SARS-CoV-2 Prep&Amp UM Kit is intended for in vitro diagnostic use and has been validated, but the FDA’s independent review of the validation is pending. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.