BactoReal® Kit H. pylori ClariRes

Detection of the 23S rRNA gene of Helicobacter pylori and determination of its clarithromycin resistance.

Background: 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: BactoReal® Kit H. pylori ClariRes is a non-automated IVD test, based on real-time polymerase chain reaction (PCR), for the qualitative detection of DNA (23S rRNA Gen) of Helicobacter pylori (H. pylori) in combination with the detection of a possible clarithromycin susceptibility. The test allows detection of a H. pylori infection with simultaneous detection of the wild-type (susceptible to clarithromycin) as well as of three most common point mutations (A2142C, A2142G, and A2143G) in the 23S rRNA gene of H. pylori responsible for resistance to treatment with clarithromycin. The wild-type sequence and the mutants are detected and distinguished by melting curve analysis in the FAM/SYBR® Green channel following amplification. The internal DNA positive control (IC) is also detected in the channel for FAM/SYBR® and is used as DNA extraction and/or as real-time PCR inhibition control. The target for the IC (artificial target DNA) is extracted with the sample or is added to the PCR reaction. Proper specimens are DNA extracts from human gastric tissue biopsies and fresh or frozen stool samples without pre-enrichment. This test is suitable for patients of all ages with suspected infection with H. pylori and is intended as an aid in the diagnosis of infection with this pathogen in combination with patient history and additional clinical information. The test is for professional use only and the use is limited to qualified personnel instructed in real-time PCR and in-vitro diagnostic procedures.

Product Features:
- Amplification and detection: 23S rRNA gene of Helicobacter pylori and Clarythromycin resistance test
- CE-IVD Real-time PCR Assay with primers, probes and two positive controls
- Internal Positive Control System to exclude false-negative results