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Showing content from https://pubmed.ncbi.nlm.nih.gov/30195193/ below:

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

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 E Peeters², I Benoy³, D Vanden Broeck⁴, J Bogers⁴, P De Sutter⁵, G Donders⁶, W Tjalma⁷, S Weyers⁸, K Cuschieri⁹, M Poljak¹⁰, J Bonde¹¹, C Cocuzza¹², F H Zhao¹³, S Van Keer¹⁴, A Vorsters¹⁴

Affiliations

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.

PMID: 30195193
DOI: 10.1016/j.jcv.2018.08.006

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

M Arbyn et al. J Clin Virol. 2018 Oct.

doi: 10.1016/j.jcv.2018.08.006. Epub 2018 Aug 22. Authors M Arbyn¹, E Peeters², I Benoy³, D Vanden Broeck⁴, J Bogers⁴, P De Sutter⁵, G Donders⁶, W Tjalma⁷, S Weyers⁸, K Cuschieri⁹, M Poljak¹⁰, J Bonde¹¹, C Cocuzza¹², F H Zhao¹³, S Van Keer¹⁴, A Vorsters¹⁴ Affiliations

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.

PMID: 30195193
DOI: 10.1016/j.jcv.2018.08.006

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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.

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