For in vitro diagnostic use. RIDA®GENE Hospital Stool Panel is a real-time multiplex RT-PCR for the direct, qualitative detection and differentiation of norovirus (genogroup I and II), rotavirus and Clostridium difficile toxin-genes A (tcdA) / B (tcdB) in human stool samples. RIDA®GENE Hospital Stool Panel real-time multiplex RT-PCR is intended for use as an aid in diagnosis of a hospital-acquired gastroenteritis.
Hospital acquired or nosocomial diarrhea is defined as an acute episode of diarrhea after 72 hours of hospitalization (3-day rule). The causes of hospital acquired diarrhea may be infectious or non-infectious (e.g. medication or chemotherapy) and affects up to one third of hospitalized patients. The most common infective cause of hospital acquired diarrhea is Clostridium difficile. Apart from Clostridium difficile other predominant infectious causes are norovirus and rotavirus. Hospital acquired diarrhea can cause serious complications in patients and increases length and costs of hospital stay.
Noroviruses cause by far the most cases of non-bacterial gastroenteritis outbreaks. A gastroenteritis caused by norovirus is manifested by severe nausea, vomiting and diarrhea. Noroviruses are egested by stool and with the vomit. An airborne transmission through aerosols containing the virus is often the cause of a very rapid spreading in shared facilities. The Center for Disease Control (CDC, Atlanta, USA) estimates that more than 21 million cases of acute gastroenteritis, 70.000 hospitalisations and 800 deaths are caused by norovirus infections each year in the United States. Noroviruses belong to the family of Caliciviridae and are small, non-enveloped viruses with a single-stranded RNA (ssRNA). They can be grouped in 7 genogroups with currently over 30 genotypes and a multiplicity of clades. So far, human pathogens have only been described from genogroup I (GI) with 9 genotypes, from genogroup II (GII) with 22 genotypes and from genogroup IV.
Rotaviruses belong to the Reoviridae family of non-enveloped, icosahedral, double-stranded RNA (dsRNA) viruses and are classified in 7 serogroups (A – G). Human infections are only caused by serogroup A, B and C, although rotavirus serogroup A accounts for more than 90 % of the infections. Symptoms of rotavirus infection are usually vomiting, watery diarrhoea and abdominal pain. The virus is transmitted by the faecal-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.
Clostridium difficile, a gram-positive, spore-forming anaerobic bacterium was first described in 1935 by Hall and O’Toole as a component of the intestinal microflora in healthy neonates. In the late 1970s, however, Clostridium difficile was identified as the cause of antibiotics-associated diarrhea and pseudomembranous colitis.15 Today Clostridium difficile is one of the most common causes of nosocomial diarrhea. Clostridium difficile is responsible for 15 – 25% of antibiotics-associated diarrhea and nearly all cases of pseudomembranous colitis. The predisposing risk factors for CDAD are for example antibiotics exposure, advanced age as well as number and duration of hospitalization. However, Clostridium difficile infection is also seen in an increasing number of non-antibiotics-treated and non-hospitalized individuals. The symptoms range from mild diarrhea to intestinal infections of variable severity, including pseudomembranous colitis, the most severe form of antibiotics-induced inflammatory bowel disease. Clinically symptomatic cases are caused by toxigenic Clostridium difficile strains that produce toxin A and toxin B. In recent years the incidence and severity of Clostridium difficile infections increased worldwide.
Real-time RT-PCR permits a rapid, highly sensitive and specific detection of the infectious cause of diarrhea. An early and reliable diagnosis of the diarrhea causing pathogen makes it possible to administer specific treatment of hospitalized patients and also to initiate hygiene measures to prevent nosocomial transmission.
|Test format||real-time RT-PCR with 100 reactions|
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.