•  MFDS IVD***

•  CE IVD

•  High clinical performance validated

*Registered trademark in South Korea.

**Not for sale in the U.S.

***Korean Ministry of Food and Drug Safety

Ezplex® HP-CLA Real-time PCR kit is an in vitro  diagnostic test that qualitatively detects helicobacter pylori and Clarithromycin-resistant mutations from human gastric biopsy tissues.

Features and Benefits

Sensitivity

Contains multiple gene targets to detect Helicobacter clarismycin-resistant mutations.

Accessibility

Genetree Viewer analysis software is provided, allowing users to conveniently check results.

Clinical Performance

Clinical evaluation showed high sensitivity and specificity, proving excellent clinical performance.


Accuracy

Clinical accuracy was validated in tests conducted using human stomach biopsy samples.

Stability

Shelf life of up to 12 months.

Reproducibility

No cross-reaction occurred in repeated tests at various concentrations of different agents.

Downloadable Resources

Product Specifications

Kit Information
- Kit includes Taq polymerase, Primer, Probe, Positive Control and Internal Control.

Clinical Sensitivity & Specificity

- Helicobacter pylori: clinical Sensitivity of 100% (95% CI, 95.6-100%) and clinical specificity of 100% (95% CI, 94.56-100%)
- A2142G: clinical sensitivity of 100% (95% CI, 92.45-100%) and clinical specificity of 100% (95% CI, 94.56-100%)
- A2143G: clinical sensitivity of 100% (95% CI, 94.87-100%) and clinical specificity of 100% (95% CI, 94.56-100%)

Work Flow