Viral infectious disease IVDs

Intended purpose

The Xpert Norovirus Assay, performed on the Cepheid GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the rapid identification and differentiation of norovirus genogroup I and genogroup II from raw or unpreserved unformed stool specimens collected from individuals with symptoms of acute gastroenteritis. The test utilizes automated real-time reverse transcriptase polymerase chain reaction (rRT-PCR) to detect norovirus RNA. The Xpert Norovirus Assay is intended to aid in the diagnosis of norovirus infections.