HPV DNA detection in urine samples of women: ‘an efficacious and accurate alternative to cervical samples?’

Pattyn, Jade; Keer, Severien Van; Téblick, Laura; Damme, Pierre Van; Vorsters, Alex

doi:10.1080/14787210.2019.1668776

Cited by 21 publications

(30 citation statements)

References 22 publications

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“…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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show abstract

“…Currently, there remains some confusion regarding the definition of first-void urine, which should refer to the initial stream of urine but is sometimes defined as the first urine of the day. Next to the use of first-void urine, other keynotes for improved HPV DNA detection in FV urine were recently summarized (17). Rwanda and Bhutan were the first countries to show the impact of HPV vaccination using optimized urinary HPV DNA testing, confirming the relevance of this sample as representative of the genital tract.…”

Section: Rationale To Detect Vaccine-induced Hpv Antibodies In First-mentioning

confidence: 99%

Non-invasive Assessment of Vaccine-Induced HPV Antibodies via First-Void Urine

et al. 2020

Self Cite

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The potential of first-void (FV) urine as a non-invasive method to monitor human papillomavirus (HPV) vaccination has been reported, mainly focusing on urine as a sample to assess HPV DNA. Besides HPV DNA, vaccine-induced HPV antibodies originating from cervicovaginal secretions were recently shown to be detectable in FV urine as well. This presents a novel opportunity for non-invasive sampling to monitor HPV antibody status in women participating in large epidemiological studies and HPV vaccine trials. The simultaneous assessment of both HPV infection and immunogenicity on a non-invasive, readily obtained sample is particularly attractive.

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“…Nevertheless, even with the vaginal self-sampling offer, some women are still not engaged in screening, possibly explained by the woman's uncertainty about proper self-sampling including fear of injuries and discomfort touching herself [5]. Urine samples may be considered as an alternative self-sampling screening option as it is cheap, non-invasive and straightforward to collect [6][7][8].…”

Section: Introductionmentioning

confidence: 99%

Urine collection in cervical cancer screening – analytical comparison of two HPV DNA assays

Tranberg

Jensen²,

Bech

et al. 2020

BMC Infect Dis

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Background To reach non-participants, reluctant to undergo clinician-based cervical cancer screening and 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 vaginal self-samples and cervical cytology samples taken by the general practitioner (GP). We also studied women’s acceptance of urine collection and preferences towards the different sampling procedures. Methods One hundred fifty paired self-collected urine and 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 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 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 vaginal self-sampling and cervical sampling for hrHPV detection was found compared to CLART. Urinary hrHPV detection with COBAS 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 vaginal self-sampling.

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HPV DNA detection in urine samples of women: ‘an efficacious and accurate alternative to cervical samples?’

Cited by 21 publications

References 22 publications

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

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

Non-invasive Assessment of Vaccine-Induced HPV Antibodies via First-Void Urine

Urine collection in cervical cancer screening – analytical comparison of two HPV DNA assays

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