HPV-Risk assay

Qualitative detection of 14 high-risk HPV types (HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 67, 68) as well as putative HPV high risk type 67, with separate identification of HPV16 and 18 in one test.

Fully clinically validated HPV screening method to identify women at risk for cervical (pre)cancer using either cervical scrape or self-collected vaginal sample.

Special Features:

  • Design based on E7 target region:
    • Overcomes potential false-negative results caused by viral DNA integration during cancer development
  • HPV types detected:
    • 14 hrHPV types: HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 67, 68 as well as putative HPV high risk type 67
  • Fully clinically validated:
    • Compliance to International Screening Guidelines for HPV DNA tests1,2,3 
  • Flexible:
    • Suitable for different sample types including self-collected samples
    • Compatible with common DNA extraction methods
  • Reliable:     
    • Build-in check for sample quality ensuring reliable results 
  • Easy:
    • Limited hands-on time due to the ready-to-use master mix

HPV-Risk assay is a registered trademark of the legal manufacturer, Self-screen B.V., the Netherlands, and is distributed by Fujirebio Europe.

CE marked
HPV-Risk Assay

Product number 81353

72 Tests
Please contact your local Fujirebio representative for the availability of this product in your country.
Self-screen HPV-Risk assay

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    Technical Specifications:

    • Method:
      • Real-time multiplex PCR
    • HPV types detected:
      • 14 hrHPV types: HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 67, 68 as well as putative HPV high risk type 67
    • Sample types:
      • Cervical scrape samples stored in PreservCyt® Solution, SurePath™, Cell Solutions and PathTezt collection medium
      • Self-collected vaginal brush samples
      • Formalin-fixed-paraffin-embedded (FFPE) biopsy (RUO)
    • Target:
      • E7 region
    • Sample volume:
      • 5 µL DNA-extract
    • Reaction time:
      • Total time to result: within one working day (incl. DNA extraction)
        HPV Risk Assay:
      • Run time in real-time PCR cycler: within 60 minutes
      • Hands-on time : 20 minutes
    • Equipment:​​​​​​
      • Mic qPCR Cycler (Bio Molecular Systems)
      • QPCR software (Bio Molecular Systems)
      • HPV-Risk Mic v1.0 mic template  

     

    Reference papers: 

    1. Clinical validation of the HPV-Risk Assay, a novel real-time PCR Assay for detection of High-Risk human papillomavirus DNA by targeting the E7 region. A.T. Hesselink et al. J Clin Microbiol March 2014 volume 52
    2. Evaluation of the clinical performance of the HPV-Risk assay using the VALGENT-3 panel. N.J. Polman et al. J Clin Microbiol 55:3544-3551
    3. Clinical performance of the HPV-Risk assay on cervical samples in SurePath medium using the VALGENT-4 panel. D.A.M. Heideman et al. J Clin Microbiol 121 (2019) 104201

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