H. pylori ClariRes Assay (CE-IVD)

 

Hpylori ClariRes Assay IVDHpylori ClariRes Eppi

 

 

Helicobacter pylori colonizes the human stomach and is associated with gastritis and gastroduodenal ulcer and gastric cancer. Infection with Helicobacter pylori can be effectively treated with proton pump inhibitors and various antibiotics. Clarithromycin is an integral part of first line therapies to treat Helicobacter pylori infection. Since clarithromycin is a widely used antimicrobial drug, the prevalence of clarithromycin resistant Helicobacter pylori strains is increasing continuously.

H. pylori ClariRes Assay is a real-time PCR test for the simultaneous detection of Helicobacter pylori  and of a clarithromycin resistance by melting curve analyses. The test allows the examination of DNA extracted from fresh or frozen stool or biopsies without pre-enrichment. The non-invasive Helicobacter pylori detection in combination with clarithromycin susceptibility testing from stool samples provides a convenient monitoring of a Helicobacter pylori infection for the patient.

For Helicobacter pylori DNA purification from fresh or frozen stool samples, ingenetix recommends the H. pylori DNA Stool Extraction Kit.

Product H. pylori ClariRes Assay
Order nr. RTGM100
Unit 50 reactions
CE-IVD Yes
Technology Real-time PCR
Kit content Assay
Internal positive control
Positive controls
Water
Manual (for LightCycler® 1.1/1.2/1.5/2.0)
Target gene 23S rDNA
Detection 670 nm (F3)
Validated PCR-platforms* LightCycler® 1.1/1.2/1.5/2.0
Additionally required PCR-reagents LC™-FastStart DNA Master SYBR® Green I

*Test has been validated for LightCycler® 1.1/1.2/1.5/2.0. For LightCycler® 480 evaluation data are not yet available.

 

Manual v2.4e: Download pdf

Material Safety Data Sheet: Download pdf

Declaration of conformity: Download pdf

 

Literature link:

 

H pylori Claires Assay PCR       helicobacter pylori clarithromycin

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