Intended use:

For in vitro diagnostic use. RIDA®GENE ETEC/EIEC is a multiplex real-time PCR for the direct, qualitative detection and differentiation of the virulence-factor genes of ETEC and EIEC/Shigella spp. in human stool samples and cultures. RIDA®GENE ETEC/EIEC multiplex real-time PCR is intended for use as an aid in diagnosis of gastroenteritis caused by pathogenic Escherichia coli and Shigella spp., respectively.

General information:

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 nonpathogenic. Some E. coli strains are pathogenic to humans through the acquisition of certain virulence factors (e.g. genes for toxins).

The six known intestinal pathogenic E. coli: enterohemorrhagic E. coli (EHEC), enteropathogenic 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.

Enterotoxigenic E. coli (ETEC) are important intestinal pathogenic E. coli. ETEC is the most common cause of traveller’s diarrhea that affects persons travelling to developing countries. 30 – 60 % of all traveller’s diarrhea cases are caused by ETEC. 11 – 16 % of returning travellers from developing countries are infected by ETEC. Among children below 5 years of age in developing countries, ETEC accounts for about 210 million cases of diarrhea and about 380,000 deaths annually. ETEC has two important diagnostic virulence factors. They are capable to produce heat stable (ST) and/or heat labile (LT) enterotoxins. The clinical symptoms which are caused by ETEC range from mild to acute watery diarrhea, which fade without any specific therapy. Life-threatening cases of ETEC diarrhea occur mostly in weanling infants in the developing countries. Sources of infection are contaminated water and food, whereas infective chains from human to human can be excluded so far.

Enteroinvasive E. coli (EIEC) are responsible for Shigellose-like disease in developing countries and among travellers to these less developed regions. EIEC strains are biochemically and genetically related to Shigella spp. The pathogenic features of EIEC and Shigella spp. are based on plasmid-mediated capability to invade the colonic epithelium for destruction. By the detection of the ipaH gene (invasion plasmid antigen H gene) EIEC/Shigella spp. can be differentiated from ETEC. A differentiation between EIEC and Shigella spp. is not recommended, because both have the same clinical relevance. Shigellose caused by EIEC is characterized by abdominal pain and watery diarrhea, sometimes containing blood. Sources of infection are contaminated water, food and infective chains from human to human.

Specifications
Art. No. PG2225
Test format real-time PCR with 100 reactions
Shelf life 24 months after production
Sensitivity Analytical Sensitivity
LT: ≥ 10 DNA copies per reaction
ST: ≥ 10 DNA copies per reaction
ipaH: ≥ 10 DNA copies per reaction
Files
InstructionsGerman
English
German - valid with new lot XXXXXN
English - valid with new lot XXXXXN
Spanish - valid with new lot XXXXXN
French - valid with new lot XXXXXN
Italian - valid with new lot XXXXXN
All - valid with new lot XXXXXN
SDSpg2225_german-1.zip (German)
pg2225_english-1.zip (English)
pg2225_french-1.zip (French)
pg2225_spanish-1.zip (Spanish)
pg2225_italian-1.zip (Italian)
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