•  MFDS IVD***

•  Qualitative detection of virus that causes Severe Fever with thrombocytopenia Syndrome

•  PCR reaction of 96 samples

*Registered trademark in South Korea.

**Not for sale in the U.S.

***Korean Ministry of Food and Drug Safety

Ezplex® SFTS Virus Real-time PCR Kit is an in vitro diagnostic test intended for the qualitative detection of the Dabie bandavirus that causes Severe Fever with thrombocytopenia Syndrome using nucleic acid RNA extracted from human blood or serum.

Features and Benefits

Sensitivity

Repeated tests through serial dilution confirmed high analytical sensitivity.

Accuracy

Clinical evaluation performed with human blood specimens confirmed clinical accuracy.

Clinical Performance

Excellent clinical performance with high sensitivity and specificity proven.

Accessibility

Analysis software provided enables automated analysis.

Stability

Shelf life of up to 6 months.

Reproducibility

High reproducibility with similar results were confirmed various tests.

Product Specifications

Kit Information
- Kit includes Taq Polymerase, Primer & Probe, Positive control.

Clinical Sensitivity & Specificity

- SFTS Virus: clinical sensitivity (95% CI) of 94.31-100% and clinical specificity (95% CI) of 94.04-100%.


Work Process