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

Arbyn, Marc; Peeters, Eliana; Benoy, Ina; Broeck, Davy Vanden; Bogers, Johannes; Sutter, Philippe De; Donders, Gilbert; Tjalma, Wiebren A.A.; Weyers, Steven; Cuschieri, Kate; Poljak, Mario; Bonde, Jesper; Cocuzza, Clementina; Zhao, Fanghui; Keer, Severien Van; Vorsters, Alex

doi:10.1016/j.jcv.2018.08.006

Cited by 76 publications

(57 citation statements)

References 54 publications

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“…This particular method was not covered in this review as there is a paucity of data on the predictive value of a urine HPV positive result as it relates to clinical outcomes such as histologically-confirmed high-grade cervical disease. There is currently a diagnostic test accuracy study being undertaken called Validation of Human Papillomavirus Assays and Collection Devices for Self-samples and Urine Samples (VALHUDES) [58], which seeks to examine the clinical sensitivity and specificity of urine, and vaginal self-collected samples, against both a clinician-collected samples and against the histological diagnosis of followed up cases. It is likely that VALHUDES will address a number of other issues surrounding the development of a standardized urine collection and testing protocol [59], although this trial utilises a specific urine collection device, the Colli-Pee (Novosanis NV, Wijnegem, Belgium), which may be cost prohibitive in low-and middle-income countries.…”

Section: Discussionmentioning

confidence: 99%

“…Currently the wealth of evidence supports PCR-based assays for use in self-collection protocols, and this is explicitly stated in the Australian technical requirements for HPV-based cervical screening [24]. It should also be noted that most of the currently utilised mediumto high-volume HPV assays test for the same 14 HPV types; 16,18,31,33,35,39,45,51,52,56,58,59, 66, and 68. It is important to note that each different combination of device, buffer and assay/system requires validation, either by the manufacturer or by individual laboratories.…”

Section: Pcr-based Technologies For Hpv Testing Of Self-collected Spementioning

confidence: 99%

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Self-Collection for Cervical Screening Programs: From Research to Reality

Hawkes

Keung

Huang

et al. 2020

Cancers

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In 2018, there were an estimated 570,000 new cases of cervical cancer globally, with most of them occurring in women who either had no access to cervical screening, or had not participated in screening in regions where programs are available. Where programs are in place, a major barrier for women across many cultures has been the requirement to undergo a speculum examination. With the emergence of HPV-based primary screening, the option of self-collection (where the woman takes the sample from the vagina herself) may overcome this barrier, given that such samples when tested using a PCR-based HPV assay have similar sensitivity for the detection of cervical pre-cancers as practitioner-collected cervical specimens. Other advantages of HPV-based screening using self-collection, beyond the increase in acceptability to women, include scalability, efficiency, and high negative predictive value, allowing for long intervals between negative tests. Self-collection will be a key strategy for the successful scale up of cervical screening programs globally in response to the WHO call for all countries to work towards the elimination of cervical cancer as a public health problem. This review will examine self-collection for HPV-based cervical screening including the collection devices, assays and possible routine laboratory processes considering how they can be utilized in cervical screening programs.

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Section: Discussionmentioning

confidence: 99%

Section: Pcr-based Technologies For Hpv Testing Of Self-collected Spementioning

confidence: 99%

Self-Collection for Cervical Screening Programs: From Research to Reality

Hawkes

Keung

Huang

et al. 2020

Cancers

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“…Nicolas Wentzensen is employed by the National Cancer Institute, which has received cervical cancer screening assays in kind or at reduced cost from BD and Roche for studies on which he is working. Eliana Peeters and Marc Arbyn are researchers at Sciensano, which receives funding from the VALidation of HPV GENotyping Tests (VALGENT) and VALidation of HUman papillomavirus assays and collection DEvices for HPV testing on Self‐samples and urine samples (VALHUDES) projects to evaluate human papillomavirus assays; the researchers do not receive any material or financial advantages from these projects. The other author made no disclosures.…”

Section: Conflict Of Interest Disclosuresmentioning

confidence: 99%

Meta‐analysis of the accuracy of p16 or p16/Ki‐67 immunocytochemistry versus HPV testing for the detection of CIN2+/CIN3+ in triage of women with minor abnormal cytology

Peeters

Wentzensen

Bergeron

et al. 2019

Cancer Cytopathology

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BACKGROUND: Women with atypical squamous cells of undetermined significance (ASC-US) can be triaged accurately with a high-risk human papillomavirus (hrHPV) test to identify those who need a referral. However, the triage of lowgrade squamous intraepithelial lesion (LSIL) with hrHPV testing has very low specificity. Overexpression of p16, with or without Ki-67, indicates neoplastic transformation of human papillomavirus-infected cervical cells and may more accurately predict underlying cervical intraepithelial neoplasia of grade 3 or worse (CIN3+). METHODS: A literature search was conducted in 3 bibliographic databases. Studies were selected if they included women with ASC-US or LSIL who were triaged with dual staining (p16/Ki-67) and/or p16 staining and, if available, with a comparator hrHPV test to detect cervical intraepithelial neoplasia of grade 2 or worse (CIN2+) or CIN3+. RESULTS: Thirty-eight studies were eligible. The sensitivity of p16 staining for CIN3+ was significantly lower than that of hrHPV DNA testing (ratio for ASC-US, 0.87; 95% confidence interval [CI], 0.78-0.97; ratio for LSIL, 0.86; 95% CI, 0.80-0.93). In contrast, the specificity of p16 staining was substantially higher with relative specificities of 1.60 (95% CI, 1.35-1.88) and 2.29 (95% CI, 2.05-2.56) for ASC-US and LSIL respectively. Dual staining was as sensitive as hrHPV DNA testing but was more specific (ratio for ASC-US, 1.65; 95% CI, 1.42-1.92; ratio for LSIL, 2.45; 95% CI, 2.17-2.77). CONCLUSIONS: This meta-analysis confirms that p16 staining and p16/Ki-67 staining are more specific for CIN2+/CIN3+ than hrHPV DNA testing. Although p16 staining is less sensitive for CIN3+ than hrHPV DNA testing, dual staining has similar sensitivity.

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“…Indeed, our results support that future research should focus on optimizing the urinary (pre)-analytical procedures to improve accuracy, but also compare accuracy of hrHPV testing in paired urine and cervical samples using different combinations of urine collection methods and hrHPV assays. The ongoing VALUDES study seeks to address this current lack in evidence [32].…”

Section: Interpretation and Comparison With Previous Studiesmentioning

confidence: 99%

Urine Collection in Cervical Cancer Screening – Comparison of Two HPV DNA Assays

Tranberg¹,

Jensen

Bech

et al. 2020

Preprint

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Background: To reach non-participants, reluctant to undergo clinician-based cervical cancer screening and cervico-vaginal self-sampling, urine collection for high-risk human papillomavirus detection (hrHPV) may be valuable. Using two hrHPV DNA assays, we evaluated the concordance of hrHPV positivity in urine samples in comparison with cervico-vaginal self-samples and cervical cytology samples taken by the general practitioner (GP). We also studied women's accept of urine collection and preferences towards the different sampling procedures.Methods: One hundred fifty paired self-collected urine and cervico-vaginal samples and GP-collected cervical cytology samples were obtained from 30 to 59-year-old women diagnosed with ASC-US within the Danish cervical cancer screening program. After undergoing cervical cytology at the GP, the women collected first-void urine and cervico-vaginal samples at home and completed a questionnaire. Each sample was hrHPV DNA tested by the GENOMICA® CLART and COBAS® 4800 assays. Concordance in hrHPV detection between sample types was determined using Kappa (k) statistics. Sensitivity and specificity of hrHPV detection in urine was calculated using cervical sampling as reference.Results: With the COBAS assay, urine showed good concordance to the cervico-vaginal (k=0.66) self-samples and cervical samples (k =0.66) for hrHPV detection. The corresponding concordance was moderate (k=0.59 and k=0.47) using CLART. Compared to cervical sampling, urinary hrHPV detection had a sensitivity of 63.9% and a specificity of 96.5% using COBAS; compared with 51.6% and 92.4% for CLART. Invalid hrHPV test rates were 1.8% for COBAS and 26.9% for CLART. Urine collection was well-accepted and 42.3% of the women ranked it as the most preferred future screening procedure.Conclusions: Urine collection provides a well-accepted screening option. With COBAS, higher concordance between urine and cervico-vaginal self-sampling and cervical sampling for hrHPV detection was found compared to CLART. Urinary hrHPV detection is feasible, but its accuracy may need to be improved before urine collection at home can be offered to non-participants reluctant to both cervical sampling and cervico-vaginal self-sampling.

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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

Abstract: 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.

Cited by 76 publications

References 54 publications

Self-Collection for Cervical Screening Programs: From Research to Reality

Self-Collection for Cervical Screening Programs: From Research to Reality

Meta‐analysis of the accuracy of p16 or p16/Ki‐67 immunocytochemistry versus HPV testing for the detection of CIN2+/CIN3+ in triage of women with minor abnormal cytology

Urine Collection in Cervical Cancer Screening – Comparison of Two HPV DNA Assays

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