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Papilloplex High Risk HPV

Accuracy and Sensitivity in Design

Human papillomavirus (HPV) infection is the most common sexually transmitted infections globally. The link between persistent infection and cervical cancer has lead to the emergence of cancer screening programs to better stratify women and their risk of developing cervical cancer. Over 150 HPV types have been identified where some have been implicated as major risk factors in cervical cancer.  The clinical significance of persistence and clearance rates of virus over time on the severity and progression, as well as co-infection of high- and low-risk HPV types, have recently been identified as factors for disease progression. However, current HPV diagnostic tools are limited in their use for the detection, identification and differentiation of multiple HPV genotypes. 

 

The GeneFirst Papilloplex® High Risk HPV test has been designed to address these unmet medical needs by targeting 14 HPV genotypes to better stratify disease risk and progression. This test, based on GeneFirst’s proprietary MPA Technology, aids our understanding of genotype-specific HPV infection in developing strategies to enhance the prevention and management of cervical cancer.  ​

Key Features and Benefits

  • Simultaneous detection and differentiation of all high-risk types including 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68

  • DNA test for better sensitivity and risk stratification

  • Internal control for sample cellularity and PCR inhibition

  • Ease-of-use in a single, multiplex, real-time PCR reaction

  • Flexible, customisable throughput

Technical Specifications

  • Target sequence: E6/E7 region

  • Clinical Sensitivity: 100%

  • Limit of detection: 100 copies for all HPV types

  • Quality Control: Positive and internal cellular controls of PCR amplification and sample integrity

  • Validated sample type: Cervical (Thinprep)

  • Recommended extraction methods: Quick DNA/RNA Viral Kit (Zymo Research); Viral-PrepAdem-Kit (Ademtech)

  • Validated amplification system: Bio-Rad CFX96; SLAN96P

  • Kit storage: -20°C

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