The COVID-19 Surveillance Test Kit and COVID-19 Saliva Dx Test Kit are both molecular reverse transcriptase quantitative PCR (RT-qPCR) test kits that detect a region of the SARS-CoV-2 genome, the virus that causes COVID-19. The primary difference between the COVID-19 Surveillance Test Kit and the COVID-19 Saliva Dx Test Kit is the intended use and the way results may be returned.
COVID-19 Surveillance Test Kit
The COVID-19 Surveillance Test Kit is used to monitor the presence of COVID-19 at the community or population level. COVID-19 surveillance testing does not require reporting results to local authorities and is not currently regulated by the FDA.
Surveillance testing can be run with pooled or individual saliva specimens. An individual positive result from surveillance testing should be considered a presumptive positive or inconclusive result. In this case, refer the appropriate subject for diagnostic testing.
COVID-19 Saliva Dx Test Kit
Diagnostic testing in the United States is regulated by the FDA. The COVID-19 Saliva Dx Test Kit can be used by high complexity CLIA certified labs for individual diagnostic testing. For this use case, results must be reported to local authorities.