For in vitro diagnostic use. RIDA®GENE EHEC/EPEC is a multiplex real-time PCR for the direct, qualitative detection and differentiation of genes encoding the virulence-factors of EHEC, STEC, EPEC, EIEC/Shigella spp. in human stool samples and cultures.
RIDA®GENE EHEC/EPEC real-time PCR is intended for use as an aid in diagnosis of gastroenteritis caused by pathogenic Escherichia coli and Shigella spp., respectively.
Escherichia coli (E. coli) are gram negative, facultatively anaerobic rod bacteria which move by peritrichal flagellation and belong to the Enterobacteriaceae family. E. coli are part of the normal intestinal flora of humans and many farm animals and are generally apathogenic. Some E. coli strains are pathogenic to humans through the acquisition of certain virulence factors (eg., genes for toxins). The six known intestinal pathogenic E. coli: enterohämorrhagic E. coli (EHEC), enteropathogeic E. coli (EPEC), enterotoxic E. coli (ETEC), enteroinvasive E. coli (EIEC), EAEC enteroaggregative E. coli und diffusely adherent E. coli (DAEC) can be differentiated by the virulence factors. Enterohämorrhagic E. coli (EHEC) are currently the most important intestinal pathogenic E. coli. Every year about 1000 cases of illness due to an infection with enterohaemorrhagic E. coli (EHEC) are reported in Germany.
EHEC are a subgroup of the Shiga toxin or Verotoxin producing E. coli (STEC or VTEC) and are capable to produce two cytotoxins, Verotoxin 1 and 2. Due to the similarity of the Verotoxins to the Shiga toxin of Shigella dysenteriae, the VTEC are also called STEC. Another important diagnostic virulence factor for EHEC is the eae gene (E. coli attaching and effacing gene) encoding intimin. By the detection of the ipaH gene (invasion plasmid antigen H) EHEC/STEC can be differentiated from Shigella/EIEC. The clinical symptoms, which are caused by EHEC, range from mild diarrhoeas and severe gastroenteritis to haemorrhagic colitis which occurs in approx. 10 to 20 % of cases of infection. With 5 -10 % of infections, in babies and small children in particular as well as old patients or patients with weakened immune systems, this may also lead to a haemolytic uraemic syndrome (HUS) or thrombotic thrombocytopenic purpura (TTP) as a life-threatening post-infectious complication. With HUS and TTP, mortality is particularly high among infants (approx. 10 – 15%). Enteropathogenic E. coli (EPEC) cause particularly in infants younger than 2 years diarrhea. The virulence factor for EPEC is the eae gene.
|Test format||real-time PCR with 100 reactions|
|Shelf life||24 months after production|
stx1/stx2: ≤ 10 DNA copies per reaction
eae: ≤ 10 DNA copies per reaction
ipaH: ≤ 10 DNA copies per reaction
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.