The NeoPlexTM COVID-19 Detection Kit Assay is a real-time RT-PCR in vitro diagnostic test intended for the qualitative detection of RNA from SARS-CoV-2 isolated and purified from respiratory specimens* obtained from individuals who meet COVID-19 clinical and/or epidemiological criteria. The NeoPlexTM COVID-19 Detection Kit is for use only under Emergency Use Authorization (EUA) in the US laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.�§263a, to perform high complexity tests.
