Background: A non-invasive H. pylori detection in combination with clarithromycin susceptibility testing from stool samples provides a convenient monitoring of a H. pylori infection for the patient. Helicobacter pylori colonizes the human stomach and is associated with gastritis and gastroduodenal ulcer and gastric cancer. At present, several diagnostic tests for H. pylori detection are available. Invasive methods requiring gastric endoscopy include rapid urease testing, culture, histology and molecular diagnostics. Non-invasive approaches include faecal antigen detection, serologic testing, urea breath testing and molecular diagnostics. Infection with H. pylori can be effectively treated with proton pump inhibitors and various antibiotics. Clarithromycin is an integral part of first line therapies to treat H. pylori infection. Since clarithromycin is a widely used antimicrobial drug, the prevalence of clarithromycin resistant H. pylori strains is increasing continuously. Resistance to clarithromycin is mainly due to three major point mutations at two positions (A2142C, A2142G, and A2143G) within the peptidyltransferase region of the 23S rRNA of H. pylori.
Description: H. pylori ClariRes Assay is an ivD-certified test for the simultaneous detection of H. pylori and of the three major point mutations in the 23S rRNA gene associated with clarithromycin resistance in H. pylori isolates. The three point mutations and the wild-type-sequence of the 23S rRNA gene of H. pylori are amplified in one PCR reaction and are subsequently differentiated by melting curve analyses at 670 nm (F3). A melting temperature of 63°C identifies the wild-type sequence of the 23S rRNA of H. pylori. A melting temperature of 58°C clearly indicates the mutant A2142C, while a melting temperature of 54°C indicates the presence of the mutants A2142G or A2143G. The presence of mixed infections results in two melting temperatures and can be interpreted up to a ratio of 1:10. A melting temperature of 47°C identifies the internal positive control. H. pylori ClariRes Assay allows the examination of DNA freshly extracted from or frozen stool or biopsies without pre-enrichment.
- Amplification and detection: 23S rRNA gene of Helicobacter pylori and Clarythromycin resistance test
- CE-IVD Real-time PCR Assay with primern, probes and two positive controls
- Internal Positive Control System to exclude false-negative results
- No amplification mix included
- Declaration of Conformity
PCR platforms: H. pylori ClariRes Assay is developed and validated for the LightCycler® 1.1/1.2/1.5/2.0 instruments (Roche).
Shipping Temperature: +4°C cool packs