For in vitro diagnostic use. The RIDA®UNITY Norovirus I & II test, performed on the RIDA®UNITY platform, is a multiplex real-time RT-PCR for the direct qualitative detection and differentiation of norovirus RNA of genogroups I (GI) and II (GII) in untreated human stool samples from people with signs and symptoms of acute gastroenteritis.
The RIDA®UNITY Norovirus I & II test is intended to support the differential diagnosis of norovirus genogroup I (GI) and II (GII) infections in patients with symptoms of gastroenteritis in connection with other clinical and laboratory findings.
Negative results do not rule out norovirus infection and should not be used as the sole basis for diagnosis.
The product is intended for professional use.
General information:
Noroviruses are one of the world’s most common causes of nonbacterial gastroenteritis in people of all age groups and result in about 70,000 to 200,000 deaths each year. They are responsible for about 20 % of all cases of acute gastroenteritis worldwide. Human noroviruses, formerly called Norwalk viruses, were first identified in 1972 in stool samples collected during an outbreak of gastroenteritis in Norwalk, Ohio, USA, making them the first viral pathogens proven to cause gastroenteritis.
Noroviruses belong to the family Caliciviridae and are small, nonenveloped viruses with single-stranded RNA (ssRNA).