Intended use:
For in vitro diagnostic use. The RIDA®Prime H. pylori BDM test, which can be performed manually or automatically, is a multiplex real-time PCR for the direct qualitative detection of
– Helicobacter pylori DNA and
– DNA of clarithromycin resistance (mutations A2142G, A2142C, A2143G)
in untreated human biopsy samples from persons with signs and symptoms of acute gastroenteritis. The RIDA®Prime H. pylori BDM test is intended to support the diagnosis of Helicobacter pylori infection and any clarithromycin resistance (mutations A2142G, A2142C, A2143G) in patients with symptoms of gastric disease in conjunction with other clinical and laboratory findings.
Negative results do not rule out infection with Helicobacter pylori or the presence of clarithromycin resistance and should not be used as the sole basis for diagnosis.
The product is intended for professional use.
General information:
Reliable PCR Detection of Helicobacter pylori and Clarithromycin Resistance
Our PCR kit for the detection of Helicobacter pylori and associated clarithromycin resistance offers a highly sensitive and specific solution for molecular diagnostics directly from untreated human biopsy samples. Helicobacter pylori (H. pylori) is a widespread bacterial pathogen that colonizes the human stomach. More than 50% of the global population is infected, and approximately 20% of these individuals are at risk of developing serious gastrointestinal diseases such as gastric ulcers, duodenal ulcers, or even gastric cancer.
Optimized for Automation – Compatible with BD MAX™
While the kit can be processed manually, its full compatibility with the BD MAX™ System unlocks significant workflow advantages. Laboratories benefit from end-to-end automation, from nucleic acid extraction to result interpretation, with minimal hands-on time and maximum efficiency.
Key Features
- Dual detection:
- H. pylori DNA
- Clarithromycin resistance
- IVDR-certified
- Sample type: Untreated human biopsy material
- Flexible workflow: Manual or fully automated processing with BD MAX™
| Art. No. | PM2305 |
|---|---|
| Test format | real time PCR with 100 reactions |
| Shelf life | 24 months |
Dear customers,
we have started to provide the documents for our products in an electronic format. These are the Instructions for Use (IFU), the Safety Data Sheets (SDS) and the Certificate of Analysis (CoA). For batches placed on the market after 01 January 2023, you can find our documents on the eIFU portal eifu.r-biopharm.com/clinic.
