VALHUDES: A protocol for validation of human papillomavirus assays and collection devices for HPV testing on self-samples and urine samples
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Arbyn et al., 2018
Aim: The VALHUDES (NCT03064087) project aims at providing high quality comparative data on clinical performance of high-risk HPV testing on self-collected urine and vaginal samples compared to clinician-taken samples.
Affiliations: AML, Sciensano and Centre for the Evaluation of Vaccination (CEV) at the University of Antwerp– Novosanis, Abbott, Roche and BD
Summary: Empirical evidence demonstrates that the relative accuracy of high-risk HPV-testing on self-samples versus clinician-taken samples is robust across clinical settings. In this perspective, the VALHUDES study protocol offers a framework for the validation of high-risk HPV assay testing using urinary and vaginal self-sampling devices that can be translated to a primary screening setting