Menu

CE-IVD. For in vitro diagnostic use.

The first product that reliably identifies Helicobacter pylori and clarithromycin resistance from stool samples and gastric biopsies.

Amplidiag® H. pylori+ClariR is designed to be used as a testing method to guide primary eradication therapy for all patients. It is a non-invasive qualitative multiplex real-time PCR test for reliably identifying both H. pylori and clarithromycin resistance directly from stool sample DNA extract and gastric biopsies. It uses a novel, innovative integrated nested PCR method to detect H. pylori and its clarithromycin resistance within the same specific PCR product. Thus, the product has minimal cross-reactivity with closely related species.

Specifications

  • Identification of H. pylori and clarithromycin resistance gene mutations
  • Identification of H. pylori: Sensitivity 91,4%, Specificity 99.2%
  • Identification of clarithromycin resistance gene mutations: Sensitivity 100.0%, Specificity 100.0%
  • Sample material: DNA extracted from stool
  • Product format: Multiplex real-time PCR kit

Target panel

  • Helicobacter pylori 23S rRNA gene
  • Clarithromycin resistance: SNPs at sites 2142 and 2143 of 23S rRNA gene



Key Benefits

  • Non-invasive: directly from DNA extract of stool sample
  • Identify both H. pylori and clarithromycin resistance to guide effective primary therapy
  • Suited for high-volume screening
  • Automated results analysis with Amplidiag Analyzer software
  • Option for workflow automation with Amplidiag Easy
  • Potential to lower therapy failures and decrease the number of gastroscopies and biopsies in low-risk patients
  • Contribute to the fight against gastric cancers with increased primary eradication therapy success rates
  • Reduce overall healthcare costs related to diagnostics, treatment, and complications of H. pylori infection

How to get started?

Contact sales@mobidiag.com for more information, orders, and test use possibilities. We’re here to help!




About Helicobacter pylori and gastric cancer

H. pylori is a pathogen that colonizes on an estimated 50 % of the world’s population.

It has been estimated that half of the world’s population is colonized with H. pylori. The majority of people are asymptomatic, but long-term carriage of the pathogen has been shown to increase the risk of peptic ulcers and gastric cancers. Gastric cancer is the second leading cause of cancer-related deaths. It is a global health concern, causing over one million new cases and more than 700,000 deaths annually. The IARC, an agency of WHO, has recently recommended population-based screening for H. pylori to help prevent gastric cancer.

Clarithromycin is the key antibiotic in the standard primary eradication triple therapy. Clarithromycin resistance is the most important reason for primary eradication therapy failure. Current screening methods (stool antigen tests, urea breath tests, and serological tests) cannot detect clarithromycin resistance. This diagnosis requires a gastroscopy and a gastric biopsy, successful culture and AST – method which is expensive, slow and inconvenient for the patient. To guide effective primary therapy, the potential clarithromycin resistance needs to be identified at the first phase before primary therapy.

By using a screening method capable of identifying both H. pylori and clarithromycin resistance with a non-invasive procedure, the rate of therapy failures can be lowered, the number of gastroscopies and biopsies reduced, and through effective treatment, the number of gastric cancers lowered.