Clinical validation of human papillomavirus assays (VALGENT)

Last updated on 2-4-2024 by Marie Malingreau

Project duration:

January 15, 2012

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Project with no end date

In short

Only clinically validated human papillomavirus (HPV) tests should be used in cervical cancer screening. VALGENT provides a framework enables comparison and validation of HPV genotyping assays using a relevant sample population with sufficient disease to confirm clinical performance using a validated comparator assay like the international guidelines. The VALGENT objectives are in agreement with priorities defined by the World Health Organisation and the new European Guidelines in Quality Assurance in Cervical Cancer.

Project description

The VALGENT (VALidation of HPV GENotyping Tests) framework:

facilitates the comparison and validation of HPV genotyping assays for clinically relevant outcomes using sample populations
appropriate for primary cervical cancer screening.
contains several iterative sample panels collated in countries with organized cervical cancer screening programs.

The first VALGENT study, used samples provided from AML Laboratory in Belgium. VALGENT-2 samples were collated from the Scottish Cervical Screening Programme, VALGENT-3 from cervical cancer screening in Slovenia and VALGENT-4 used samples collected from the cervical cancer screening programme in Denmark. Following the international validation guidelines, each VALGENT panel includes a standard comparator assay. The specific objectives of VALGENT include

What are potential clinical indications of HPV genotyping tests?
If clinical indications for HPV genotyping can be defined: what are minimal requirements justifying the use of genotyping tests in clinical practice?
Which HPV genotyping tests fulfil these requirements and can be recommended in clinical practice guidelines?

Results

Currently VALGENT is considered as a world standard for HPV test validation and accepted by WHO. VALGENT has and continues to generate numerous publications (see list below of 31 published articles below; the VALGENT protocol has generated 74 citations=25x the impact factor of J Clin Virol).