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.
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). Based on the genetic sequences of viral
RNA-dependent RNA polymerase and the capsid protein, noroviruses are divided into 10 genogroups (GI to GX) with currently more than 49 different genotypes (9 × GI, 27 × GII, 3 × GIII, 2 × GIV, 2 × GV, 2 × GVI, and 1 genotype each for GVII, GVIII, GIX [formerly GII.15], and GX) and a variety of strains. Genogroups I, II, and sometimes IV are the most important in terms of human pathogenicity. In the United States, more than 99 % of all norovirus outbreaks are caused by GI and GII viruses. Gastroenteritis due to noroviruses is often caused by the presence of virions in feces and vomit, whereas it takes only 10 infectious particles to cause disease. The high environmental stability and low infection dose make for high transmissibility of the norovirus. Typical symptoms of norovirus infections are diarrhea, vomiting, and nausea.
|Test format||real-time PCR with 96 reactions|
|Shelf life||18 month after production|
we have started to provide the documents for our products in an electronic format. These are the Instructions for Use (IFU), the Safety Data Sheets (SDS) and the Certificate of Analysis (CoA). For batches placed on the market after 01 January 2023, you can find our documents on the eIFU portal eifu.r-biopharm.com.