The Ezplex^® HPV NGS kit is an in vitro diagnostic medical device that detects or simultaneously detects the genotype of human papillomavirus (HPV) using Next Generation Sequencing technology (NGS). NGS instrument uses Ion Chef/S5 automated workflow to dramatically reduce hands-on time, making it easier to analyze 100 types of HPV including high risk types.

The Ezplex^® HPV kit contains all reagents for library construction, such as PCR reaction mixture, primer mixture, barcode plate, and water. Also, it contains UNG(Uracil-N-glycosylase) in PCR reaction Mixture to prevent carry over contamination.

▶Product Composition

-240 Test

With our superior “Amplification barcoding” technology and software, we provide fast and accurate results from library construction to genotype analysis

With our superior “Amplification barcoding” technology and software, we provide fast and accurate results from library construction to genotype analysis

HPV type analysis results can be found in software. The results of the analysis are exported to Excel and the virus type and quantity (+,++,+++) are displayed. If a co-infected HPV type is present, all types are displayed regardless of the number of infection types.

*  +: weak risk

++: high risk

▶Clinical Sensitivity & Specificity

Clinical sensitivity and specificity were 98.1%~100% for HPV types and 100% for HPV types, respectively. As a result of comparison with other test methods, the correlation between positive samples ranged from 88.9% to 100%, and the correlation between negative samples was 99.4% to 100%

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