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J Clin Virol. 2018 Oct;107:52-56. doi: 10.1016/j.jcv.2018.08.006. Epub 2018 Aug 22.

VALHUDES: A protocol for validation of human papillomavirus assays and collection devices for HPV testing on self-samples and urine samples.

Author information

1
Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium. Electronic address: marc.arbyn@sciensano.be.
2
Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium.
3
Laboratory of Molecular Pathology, AML Sonic Healthcare, Antwerp, Belgium; National Reference Centre for HPV, Brussels, Belgium; AMBIOR, Laboratory for Cell Biology & Histology, University of Antwerp, Antwerp, Belgium.
4
Laboratory of Molecular Pathology, AML Sonic Healthcare, Antwerp, Belgium; National Reference Centre for HPV, Brussels, Belgium; AMBIOR, Laboratory for Cell Biology & Histology, University of Antwerp, Antwerp, Belgium; International Centre for Reproductive Health, Ghent University, Ghent, Belgium.
5
UZ Brussel - VUB, dept Gynaecology-Oncology, Brussels, Belgium.
6
Department of Obstetrics and Gynaecology of the General Regional Hospital Heilig Hart, Tienen, Belgium; Femicare vzw, Clinical Research for Women, Tienen, Belgium; Department of Obstetrics and Gynaecology University Hospital Antwerpen, Antwerp, Belgium.
7
Multidisciplinary Breast Clinic, Unit Gynaecologic Oncology, Department of Obstetrics and Gynaecology, Antwerp University Hospital (UZA), Edegem, Belgium; Molecular Imaging, Pathology, Radiotherapy, Oncology (MIPRO), Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
8
Department of Obstetrics and Gynecology, Ghent University Hospital, Ghent, Belgium.
9
Scottish HPV Reference Laboratory, Department of Laboratory Medicine, NHS Lothian, Royal Infirmary of Edinburgh, United Kingdom.
10
Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
11
Molecular Pathology Laboratory, Dept. Pathology, Copenhagen University Hospital, Hvidovre, Denmark.
12
Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.
13
Department of Epidemiology, Cancer Institute of Chinese Academy of Medical Sciences, Peking Union Medical College, Department of Gynaecology and Obstetrics, Beijing Tongeren Hospital, Beijing, China.
14
Centre for the Evaluation of Vaccination (CEV), Vaccine & Infectious Disease Institute (VAXINFECTIO), Faculty of Medicine and Health Sciences, University of Antwerp, Wilrijk (Antwerp), Belgium.

Abstract

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT03064087.

KEYWORDS:

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

PMID:
30195193
DOI:
10.1016/j.jcv.2018.08.006
[Indexed for MEDLINE]

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