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

•VALHUDES is a protocol for validation of HPV tests applied on vaginal self-samples and urine specimen.•VALHUDES will generate the first clinical data regarding the accuracy of HPV tests on vaginal & urine samples.•VALHUDES will generate comparative data sets for different combinations of HPV te...

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Vydané v:Journal of clinical virology Ročník 107; s. 52 - 56
Hlavní autori: Arbyn, M., Peeters, E., Benoy, I., Vanden Broeck, D., Bogers, J., De Sutter, P., Donders, G., Tjalma, W., Weyers, S., Cuschieri, K., Poljak, M., Bonde, J., Cocuzza, C., Zhao, F.H., Van Keer, S., Vorsters, A.
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: Netherlands Elsevier B.V 01.10.2018
Predmet:
Adult
Belgium
Cervical cancer
Cervical Intraepithelial Neoplasia - diagnosis
Cervical Intraepithelial Neoplasia - virology
Cervix Uteri - virology
Colposcopy
Diagnostic test accuracy
DNA, Viral - genetics
DNA, Viral - isolation & purification
Early Detection of Cancer - instrumentation
Early Detection of Cancer - methods
Female
Humans
Mass Screening - methods
Middle Aged
Papillomaviridae - genetics
Papillomaviridae - isolation & purification
Papillomavirus Infections - diagnosis
Papillomavirus Infections - urine
Reproducibility of Results
Screening
Self-sampling
Sensitivity and Specificity
Specimen Handling - instrumentation
Specimen Handling - methods
Test validation
Urine collection
Urine Specimen Collection - instrumentation
Urine Specimen Collection - methods
Uterine Cervical Neoplasms - diagnosis
Uterine Cervical Neoplasms - virology
Vagina - virology
VALHUDES
Belgium
Self-sampling
Test validation
Screening
Urine collection
Diagnostic test accuracy
VALHUDES
Cervical cancer
ISSN:1386-6532, 1873-5967, 1873-5967
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Shrnutí:•VALHUDES is a protocol for validation of HPV tests applied on vaginal self-samples and urine specimen.•VALHUDES will generate the first clinical data regarding the accuracy of HPV tests on vaginal & urine samples.•VALHUDES will generate comparative data sets for different combinations of HPV test and self-sample devices.•VALHUDES will contribute in defining validation criteria for HPV tests on self-samples. 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. 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. 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. 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). 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.
Bibliografia:ObjectType-Article-1
SourceType-Scholarly Journals-1
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ISSN:1386-6532
1873-5967
1873-5967
DOI:10.1016/j.jcv.2018.08.006