HPV Risk Assay for screening
The HPV-Risk Assay (CE-IVD) is intended to be used for the screening of women at risk of cervical (pre)cancer.
The test is an in-vitro real-time PCR-based DNA assay for the qualitative detection of 15 (probably) high-risk human papillomavirus (HPV) genotypes: i.e. 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 67 and 68.
|Clinical sensitivity||Clinical specificity|
|CIN2+||97.1% (67/69)||94.3% (777/824)|
DNA extraction for the HPV-Risk assay can be performed fully automated using the QIAsymphony® DSP Virus/Pathogen Midi Kit including PCR set up, or semi-automated using the NucleoMag 96 Tissue kit from Macherey-Nagel (can be performed on several 96 well liquid handlers), but also manually using standard DNA extraction kits (e.g., column- and magnetic bead-based kits, such as QIAamp® DSP virus spin kit).
Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women of 30 years and older.Meijer et al. J. Cancer. 2009 February 1; 124(3): 516-520
About: What are the consensus requirements that an HPV screening assay should fulfill?
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.
Hesselink et al. J Clin Microbiol. 2014;52(3):890-896.
About: The clinical performance of the HPV-Risk Assay as HPV screenings assay, on clinician taken cervical scrapes and self-samples.
Evaluation of the Clinical Performance of the HPV-Risk Assay Using the VALGENT-3 Panel.
Polman et al, J Clin Microbiol. 2017
About: The clinical performance of the HPV-Risk Assay on PreservCyt samples compared to the HC2 reference HPV assay.
Heideman et al, J. Clin. Virol. 2019
About: The clinical performance of the HPV-Risk Assay on SurePath samples compared to the GP5+/6+-PCR-EIA reference HPV assay and GP5+/6+-PCR-EIA-LMNX.
About: Review comparing clinically validated HPV assays, demonstrating good clinical performance of HPV-Risk Assay
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