Dataset Information

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

ABSTRACT: 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.

SUBMITTER: Tranberg M

PROVIDER: S-EPMC7716507 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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

Tranberg Mette M Jensen Jørgen Skov JS Bech Bodil Hammer BH Andersen Berit B

BMC infectious diseases 20201204 1

<h4>Background</h4>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 to ...[more]

PMID: 33276740

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Project description:BackgroundCervical cancer is the fourth most common cancer affecting women worldwide, with 85% of the burden estimated to occur among women in low and middle-income countries (LMICs). Recent developments in cervical cancer screening include a novel self-collection method for the detection of oncogenic HPV strains in the collected samples. The purpose of this review is to synthesise qualitative research on self-collection for HPV-based testing for cervical screening and identify strategies to increase acceptability and feasibility in different settings, to alleviate the burden of disease.MethodsThis review includes qualitative studies published between 1986 and 2020. A total of 10 databases were searched between August 2018 and May 2020 to identify qualitative studies focusing on the perspectives and experiences of self-collection for HPV-based cervical screening from the point of view of women, health care workers and other key stakeholders (i.e., policymakers). Two authors independently assessed studies for inclusion, quality, and framework thematic synthesis findings. The Socio-Ecological Model (SEM) was used to synthesize the primary studies.ResultsA total of 1889 publications were identified, of which 31 qualitative studies were included. Using an adapted version of SEM, 10 sub-themes were identified and classified under each of the adapted model's constructs: (a) intrapersonal, (b) interpersonal, and (c) health systems/public policy. Some of the themes included under the intrapersonal (or individual) construct include the importance of self-efficacy, and values attributed to self-collection. Under the intrapersonal construct, the findings centre around the use of self-collection and its impact on social relationships. The last construct of health systems focuses on needs to ensure access to self-collection, the need for culturally sensitive programs to improve health literacy, and continuum of care.ConclusionThis review presents the global qualitative evidence on self-collection for HPV-based testing and details potential strategies to address socio-cultural and structural barriers and facilitators to the use of self-collection. If addressed during the design of an HPV-based cervical cancer screening testing intervention program, these strategies could significantly increase the acceptability and feasibility of the intervention and lead to more effective and sustainable access to cervical screening services for women worldwide.

Project description:BackgroundCervical cancer (CC) is the fourth leading cause of death from neoplasms in women and is caused by the human papilloma virus (HPV). Several methods have been developed for the screening of cervical lesions and HPV; however, some socio-cultural factors prevent women from undergoing gynecological inspection, which results in a higher risk of mortality from cervical cancer in certain population groups as indigenous communities. This study aimed to compare the concordance in HPV detection from urine and cervical samples, to propose an alternative to cervical scraping, which is commonly used in the cervical cancer screening.MethodologyThe DNA from cervical scrapings and urine samples was extracted using the proteinase K method followed by precipitation with alcohol, phenol andchloroform; a modification of the proteinase K method was developed in the management of urine sediment. Viral genotyping was performed using INNOLipa.ResultsThe study population consisted of 108 patients from an indigenous population at southern Mexico, 32 without squamous intraepithelial lesions (NSIL) and 76 with low squamous intraepithelial lesions (LSIL). The majority of NSIL cervical scrapes were negative for HPV (90.63%), whereas more than half of LSIL cases were high-risk HPV positive (51.32%), followed by multiple infection by HR-HPV (17.11%), and multiple infection by LR- and HR-HPV (9.21%). No statistically significant relationship between the cytological diagnosis and the HPV genotypes detected in the urine samples was observed. A concordance of 68.27% for HPV positivity from urine and cervical samples was observed. Similarly, a concordance of 64.52% was observed in the grouping of HPVs by oncogenic risk. HR-HPV was detected in 71% of the urine samples from women with LSIL diagnosis, which suggests that HR-HPV detected in a urine sample could indicate the presence or risk of developing SIL.ConclusionHR-HPV detection in urine samples could be an initial approach for women at risk of developing LSIL and who, for cultural reasons, refuse to undergo a gynecological inspection.

Project description:ObjectivesHuman papillomavirus (HPV) testing in cervical screening offers the potential for self-sampling to improve uptake among non-attenders. High-risk (HR) HPV detection in urine shows promise, but few studies have examined its sensitivity for cervical intraepithelial neoplasia (CIN2+) detection compared with standard cervical samples. The aims of this cross-sectional study were to optimise conditions for urine testing for HPV detection; to determine concordance for HR-HPV detection in matched urine, vaginal and cervical samples; to compare the sensitivity of HR-HPV testing for the detection of CIN2+ in matched samples; and to determine the acceptability of urine testing for cervical screening.DesignCross-sectional study.SettingSecondary care colposcopy clinic in North West England.ParticipantsWomen aged 25 years of age or older, attending colposcopy clinic for management of abnormal cervical screening results or a suspicious-looking cervix. In total, 104 women took part in the study. Triple matched samples were available for 79 and 66 women using Abbott RealTime (ART) and Roche Cobas 4800 (RC), respectively.InterventionSelf-collected urine and vaginal samples and practitioner-obtained cervical samples were tested for HR-HPV by ART and RC assays, including comparison of neat and preservative-fixed urine. Colposcopic opinion was recorded and directed cervical biopsies taken if clinically indicated. The acceptability of self-testing was evaluated by questionnaire.Primary outcome measureThe sensitivity of urine to detect underlying CIN2+.Secondary outcome measuresThe comparative sensitivity of vaginal and cervical samples to detect CIN2+; the acceptability of urine sampling.ResultsPreservative-fixed, but not neat urine, showed good concordance with vaginal samples for the detection of HR-HPV. The sensitivity for detecting CIN2+ was 15/18 (83%) for urine and 16/18 (89%) for cervical and vaginal samples by ART, and 15/17 (88%) for all samples by RC. Urine-based testing was broadly acceptable to women.ConclusionsUrinary HR-HPV detection offers an alternative strategy of cervical screening. Larger studies to determine its clinical utility are warranted.

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

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

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