Women who do not participate in cervical cancer screening programme remain at highest risk of developing invasive cervical cancer. Self-sampling devices can be offered to under screened women to increase the participation rate and prevent development of cervical cancer. Therefore, we developed a standard protocol for validation of human papillomavirus (HPV) assays and collection devices for HPV testing on vaginal and urine self-samples (VALHUDES). The protocol aims to evaluate the clinical accuracy of HPV testing to detect cervical precancer and/or cancer on self-collected samples. These validated HPV tests can be then used for detection of cervical pre-cancer and/or cancer on urine or vaginal samples collected by women themselves.
Women who do not participate in cervical cancer screening can be reached out by offering vaginal or urine self-sampling devices for HPV testing, which usually is more effective to trigger a response than a conventional invitation to contact a clinician for taking a Pap smear. Several hundreds of HPV tests are currently commercially available on the market, only few of which have been validated for cervical cancer screening following international consensus guidelines on cervical samples, but not on vaginal nor urine samples. Robust validation principles are only established for HPV testing on clinician-based samples. Therefore, we had developed a standard protocol for validation of HPV assays and collection devices for HPV testing on vaginal and urine self-samples (VALHUDES).
The VALHUDES project aims to provide high quality comparative data on clinical performance of HPV testing on self-collected samples. The current protocol compares the clinical accuracy of high risk(hr) HPV testing with defined, clinically validated PCR-based hrHPV assays on vaginal self-samples and on first-void urine, collected under standardised conditions, with hrHPV testing on matched clinician-taken samples.
HPV assay clinically validated on self-samples can be used in the contest of cervical cancer screening programs to detect cervical intraepithelial neoplasia or cervical cancer.