•  MFDS IVD***

•  CE IVD

•  Results within 2 hours post extraction

•  Detects MTBC and NTM infection

*Registered trademark in South Korea.

**Not for sale in the U.S.

***Korean Ministry of Food and Drug Safety

Ezplex® MTBC/NTM Real-time PCR Kit is an in vitro diagnostic test that simultaneously detects Mycobacterium tuberculosis complex (MTBC) and 20 types of nontuberculous mycobacteria (NTM).

Features and Benefits

Sensitivity

Multiple gene targets for MTBC and NTM.

Clinical Performance

Validated clinical performance.

Fast Results

Testing can be completed within 2 hours post extraction.

Accessibility

Genetree Viewer analysis software provided enables automated analysis.

Accuracy

Internal Control checks for PCR inhibition.

Reproducibility

High reproducibility was confirmed.

Downloadable Resources

Product Specifications

Kit Information
- Kit consists of the reagents for extraction, Taq polymerase, dNTP, Probe, Primer, Internal Control and Positive Control. Automated DNA extraction device is also compatible with the Ezplex kit.

Clinical Sensitivity & Specificity

- MTBC: clinical sensitivity of 98.6% (95% CI, 95.6-99.6%) and clinical specificity of 98.8% (95% CI, 96.3-99.7%)
- NTM: clinical sensitivity of 100% (95% CI, 96.6-100%) and clinical specificity of 100% (95% CI, 98.2-100%)