The Savvygen™ GI- Norovirus GI test allows the qualitative detection of Norovirus GI by real time RT-PCR in human feces. The product is intended for use in the diagnosis of Norovirus GI gastrointestinal infections alongside clinical data of the patient and other laboratory tests outcomes.

Noroviruses are a group of genetically diverse viruses that belong to the family Caliciviridae and that can be classified into 6 different genogroups, of which viruses from genogroup GI, GII and GIV are responsible for disease in humans. GI includes nine genotypes based on the complete major capsid protein (VP1), whereas to date, GII contains 22 genotypes. In humans, GII.4 viruses cause the majority of norovirus-related gastroenteritis outbreaks worldwide.

Noroviruses are transmitted primarily through the fecaloral route, either by direct person-to-person spread or fecally contaminated food or water. These viruses cause vomiting, nonbloody diarrhea, nausea, abdominal cramps and low-grade fever. Noroviruses are positive-sense, single-stranded, non-enveloped RNA viruses. The linear RNA genome is organized in three open reading frames (ORFs). ORF1 encodes a large polyprotein, which is cleaved by the virus encoded protease into six non-structural proteins including the viral RNA polymerase. ORF2 andORF3 encode the major and minor capsid proteins VP1 and VP2, respectively.  The ORF1-ORF2 junctionis the most highly conserved region of the genome and the best target for detection of Norovirus.

The Savvygen™ GI- Norovirus GI test is a ready-to used test which contains in each well all the necessary reagents for real time PCR assay in a stabilized format. In addition, an internal control allows the detection of a possible reaction inhibition. The amplification of the target sequence is detected through the FAM channel whereas the internal control (IC) in HEX channel.