H. pylori ClariRes lyophilised RTU qPCR CE/IVD

Intended Use
Vitassay qPCR H. pylori ClariRes allows the detection of Helicobacter pylori and clarithromycin (CLR) resistance in H. pylori by real-time PCR in gastric tissue biopsies. The product is intended for use in the diagnosis of Helicobacter pylori and clarithromycin (CLR) resistance in H. pylori infections alongside clinical data of the patient and other laboratory tests outcomes. The assay for detecting CLR resistance in H. pylori is based on detection of point mutations in the 23S rRNA gene.

Vitassay qPCR Kits contains in each well enzymes, buffer, primer and probes as well as an internal control in a lyophilized format.
The kits include a positive and a negative control.

Identification of pathogen DNA or RNA occurs by the use of target specific primers ans fluorecent labeled hydrolysis probes which hybridize conserved regions in the genomes of the different pathogens.

Kit Content:
- 4x8-well strip containg lyophilised target primer, polymerase (and reverse transciptase) and nucleotides
- Positive Control (red vial): 1 vial
- PCR grade water (white vial): 1 vial
- Resuspension Buffer (green vial): 1 vial x1 mL
- Negative control (yellow):1 vial x 1 mL
- Optical caps: 4x8 cap strip
- For quantitative assay: target specific standard

Kit Format:
qualitative