Intended use:

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) and 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.

General information:

Hospital acquired or nosocomial diarrhea is defined as an acute episode of diarrhea after 72h 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.

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. Symptoms of rotavirus infection are usually vomiting, watery diarrhoea and abdominal pain Human infections are only caused by serogroup A, B and C, although rotavirus serogroup A accounts for more than 90 % of the infections. Clostridium difficile associated diarrhea (CDAD) is one of the most common causes of nosocomial infections in industrialized countries. CDAD typically occurs after antibiotic medications. The clinical spectrum of CDAD ranges from diarrhea to severe life-threatening pseudomembranous colitis. The clinical signs of toxic Clostridium difficile (C. difficile) strains are caused due to the production of the enterotoxin A and/or cytotoxin B. C. difficile are highly contagious and are transmitted through the faecal-oral route by person to person or from environmental contaminated surfaces. Outbreaks can occur in hospitals, nursing homes and other extended-care facilities. The cost of CDAD on the health care system is estimated to be €3 billion per year for the European Union and $1.1 billion per year in the United States. In the recent years the morbidity and severity of C. difficile infection has increased significantly. 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.

Specifications
Art. No. PG0705
Test format real-time RT-PCR with 100 reactions
Shelf life 24 months after production
Sensitivity Analytical Sensitivity :
Norovirus: ≥ 50 RNA copies per reaction
Rotavirus: ≥ 50 RNA copies per reaction
CD Toxin A/B: ≥ 10 DNA copies per reaction
Files
InstructionsGerman
English
SDSPG0705_german.zip (German)
PG0705_english.zip (English)
PG0705_french.zip (French)
PG0705_italian.zip (Italian)
PG0705_spanish.zip (Spanish)
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