Ezplex® HP/CLA Real-Time PCR Kit

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.

Sensitivity

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

Clinical Performance

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

Accessibility

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

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.

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%)

Product Brochure

IFU CE IVD