• M Arbyn
  • E Peeters
  • I Benoy
  • D Vanden Broeck
  • J Bogers
  • P De Sutter
  • G Donders
  • W Tjalma
  • S Weyers
  • K Cuschieri
  • M Poljak
  • J Bonde
  • C Cocuzza
  • F H Zhao
  • S Van Keer
  • A Vorsters

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.

Original languageEnglish
Pages (from-to)52-56
Number of pages5
JournalJournal of Clinical Virology
Publication statusPublished - Oct 2018

    Research areas

  • Cervical cancer, Diagnostic test accuracy, Screening, Self-sampling, Test validation, Urine collection, VALHUDES

ID: 44200513