Intended use:

For in vitro diagnostic use. RIDA®GENE Viral Stool Panel II is a multiplex real-time RT-PCR for the direct, qualitative detection and differentiation of rotavirus, adenovirus 40/41 and astrovirus in human stool samples. The RIDA®GENE Viral Stool Panel II multiplex real-time RT-PCR is intended for use as an aid in diagnosis of gastroenteritis caused by rotavirus, adenovirus 40/41 and astrovirus, respectively.

General information:

Acute Gastroenteritis is one of the main causes of morbidity and mortality worldwide. Especially in children, enteral viruses are the primary cause of gastroenteritis. In the US, viral infections cause approximately 30.8 million cases of gastroenteritis, yearly. The most important pathogens causing diarrhea are rotavirus, adenovirus and astrovirus.
Rotaviruses belong to the Reoviridae familiy of non-enveloped icosahedral double-stranded RNA (dsRNA) viruses. Symptoms of rotavirus infection are usually vomiting, watery diarrhoea and abdominal pain. The virus is transmitted by the fecal-oral route through contaminated hands and objects. Rotavirus is the main cause of diarrhoea in children aged under five and is responsible for the death of an estimated 611,000 children worldwide each year. Rotaviruses are classified in seven serogroups A – G, whereby the viruses of serogroup A are of major epidemiologic importance.
Astroviruses are single-stranded (ssDNA) viruses and belong to the family of Astroviridae. An astroviral-dependent Gastroenteritis is primarily manifested by dirarrhoea, but can also be accompanied by vomiting and fever. In developed countries, the astrovirus incidence is between 2 – 9%, where the disease mainly affects children under the age of two. Today, there are 8 serotypes described, with serotypes 1 to 5 being most relevant. The infection is transmitted by contaminated foods, by water and by the fecal-oral route.
Adenoviruses belong to the Adenoviridae family of non-enveloped icosahedral double-stranded (dsDNA) viruses. One differentiates 56 serotypes of human adenoviruses and they are classified into seven groups (A – G). Adenoviruses mainly cause respiratory diseases, whereas gastroenteritis is primarily caused by serotype 40 and 41. The serotypes 1, 2, 5, 6, 12, 18, and 31 are rarely associated with acute diarrhea and therefore not detected by this real-time PCR assay.

Specifications
Art. No. PG1325
Test format real-time RT-PCR with 100 reactions
Files

Dear customers,

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.

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