HPV HR Detection

CE-IVDR

WHO recommends DNA testing for primary cervical cancer screening and the recent trends show that screening method is shifting from the cytology test to HPV DNA test. Furthermore, the prevalence of HPV type is different across the world due to increasing vaccination and difference in regional characteristics, leading DNA testing more useful in screening HPVs.

Allplex™ HPV HR Detection is a multiplex real-time PCR assay that enables simultaneous amplification and detection of target nucleic acids of 12 high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) and 66, 68 as well as Internal Control (IC)

Human Papillomavirus Infections

Key Features

Short PCR turn-around time (TAT)
- 1.5 hours of PCR TAT
Fully automated workflow
- Application of Seegene STARlet-AIOS™ providing one streamlined workflow from nucleic acids extraction to result analysis
Self-collected samples
- Increased accessibility of HPV screening due to alternative sample collection method, enabling early prevention of cervical cancer
12 high-risk HPV and 66, 68 genotypes
- Detecting and identifying 14 individual HPVs simultaneously with a single test
- Monitoring of clearance and persistence of HPV genotypes and the risk of cervical cancer

Specification

Analytes

- 12 high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) and 66, 68
- Internal control (IC)

Specimens

- Cervical specimen
- Self-collected vaginal specimen

Compatible Instrumentation (CE-IVD Marked)

Real-time PCR
- CFX96™ Real-time PCR Detection System
- CFX96™ DX System
- CFX Opus 96 Dx
Automated Extraction
- SEEPREP32™
Automated Extraction & PCR Setup
- Seegene STARlet
- Seegene STARlet-AIOS™
- Seegene STARlet 96MPH
- Seegene NIMBUS