TY - JOUR T1 - VALHUDES: A protocol for validation of human papillomavirus assays and collection devices for HPV testing on self-samples and urine samples. JF - J Clin Virol Y1 - 2018 A1 - M. Arbyn A1 - I Benoy A1 - D Vanden Broeck A1 - J Bogers A1 - P De Sutter A1 - G Donders A1 - W Tjalma A1 - S Weyers A1 - Cuschieri, K A1 - Poljak, M A1 - J Bonde A1 - C Cocuzza A1 - F H Zhao A1 - S Van Keer A1 - A Vorsters ED - E Peeters KW - cervical cancer KW - diagnostic test accuracy KW - SCREENING KW - self-sampling KW - Test validation KW - Urine collection KW - VALHUDES AB -

BACK GROUND: Systematic reviews have concluded that hrHPV DNA testing using target-amplification tests is as accurate on vaginal self-samples as on clinician-taken specimens for the detection of cervical precancer. However, insufficient evidence is available for specific HPV assay/self-sample device combinations.

OBJECTIVES: The VALHUDES protocol is designed as a diagnostic test accuracy study that aims to compare the clinical sensitivity and specificity of particular hrHPV assay(s) on vaginal self-samples and first-void-urine, collected in agreement with standardized protocols, with hrHPV testing on matched clinician-taken samples.

STUDY DESIGN: Five hundred enrolled women referred to a colposcopy clinic are invited to collect a first-void urine sample and one or more vaginal self-samples with particular devices before collection of a cervical sample by a clinician. Sample sets are subsequently analysed in a laboratory accredited for HPV testing. Disease verification for all enrolled patients is provided by colposcopy combined with histological assessment of biopsies.

RESULTS: A first VALHUDES study has started in Belgium in December 2017 with enrolment from four colposcopy centres. The following assays are foreseen to be evaluated: RealTime High Risk HPV assay (Abbott), cobas-4800 and -6800 (Roche), Onclarity (BD), Xpert HPV (Cepheid) and Anyplex II HPV HR (Seegene).

CONCLUSION: Given empirical evidence that the relative accuracy of HPV-testing on self- vs clinician-samples is robust across clinical settings, the VALHUDES protocol offers a framework for validation of HPV assay/self-sample device combinations that can be translated to a primary screening setting.

VL - 107 M3 - 10.1016/j.jcv.2018.08.006 ER -