Racial and Ethnic Differences in Acceptability of Urine and Cervico-Vaginal Sample Self-Collection for HPV-Based Cervical Cancer Screening

Rohner, Eliane; McGuire, F. Hunter; Liu, Yutong; Li, Quefeng; Miele, Kate; Desai, Siddhi; Schmitt, John W.; Knittel, Andrea K.; Nelson, Julie A.; Edelman, Claire; Sivaraman, Vijay; Baker, Anna; Romocki, LaHoma Smith; Rahangdale, Lisa; Smith, Jennifer S.

doi:10.1089/jwh.2019.8132

Cited by 21 publications

(21 citation statements)

References 35 publications

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“…This increased interest in self-sampling in light of the pandemic was recently reported [33,34]. Urine sampling using either a standard urine container or the Colli-Pee device is a non-invasive, easy to collect method that has been well accepted by women (Pauwels, submitted) [9][10][11][12][13][14]17], and has been rolled out in population based pilot programs in a primary screening setting [23,24] and as a tool to reach screening non-responders [35,36]. In contrast to its acceptability, little evidence was available until now about the clinical performance of hrHPV testing using validated PCRbased assays in urine collected under standardized conditions.…”

Section: Discussionmentioning

confidence: 99%

“…Additionally, urine-based self-sampling provides a more preferred alternative [9][10][11][12][13][14], which is noninvasive and easily collected, however, data on the clinical accuracy of hrHPV detection in urine used in population-based screening settings are still scarce. Pathak (2014) reported an overall pooled virological sensitivity and specificity of HPV testing in urine (all possible fractions) of 77% (95% CI (confidence interval): 68-84%) and 88% (95% CI: 58-97%), respectively, to detect hrHPV in cervical samples.…”

Section: Introductionmentioning

confidence: 99%

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Clinical and analytical evaluation of the RealTime High Risk HPV assay in Colli-Pee collected first-void urine using the VALHUDES protocol

Keer

Peeters

Broeck

et al. 2021

Gynecologic Oncology

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ObjectiveUrine self-sampling has gained increasing interest for cervical cancer screening. In contrast to analytical performance, little information is available regarding the clinical accuracy for high-risk Human Papillomavirus (hrHPV) testing on urine. MethodsVALHUDES is a diagnostic test accuracy study comparing clinical accuracy to detect high-grade cervical precancer (CIN2+) of HPV testing on self-collected compared to clinician-collected samples (NCT03064087). Disease outcome was assessed by colposcopy and histology. The Abbott RealTime High Risk HPV assay performance was evaluated on Colli-Pee collected first-void urine with cervical outcomes as comparator.3 ResultsAs no assay cut-off for urine has been clinically validated, we used the predefined cut-off for cervical samples (CN≤32). Using this cut-off, hrHPV testing was similarly sensitive (relative sensitivity 0.95; 95% CI:0.88-1.01) and specific (relative specificity 1.03; 95% CI:0.95-1.13) for detection of CIN2+ compared to testing cervical samples. In the subgroup of women of 30 years and older, similar relative sensitivity (0.97; 95% CI:0.89-1.05) and specificity (1.02; 95% CI:0.93-1.12) was found. Additionally, an exploratory cut-off (CN≤33.86) was defined which further improved sensitivity and analytical test performance. ConclusionHrHPV-DNA based PCR testing on home-collected first-void urine has similar accuracy for detecting CIN2+ compared to cervical samples taken by a clinician.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Clinical and analytical evaluation of the RealTime High Risk HPV assay in Colli-Pee collected first-void urine using the VALHUDES protocol

Keer

Peeters

Broeck

et al. 2021

Gynecologic Oncology

View full text Add to dashboard Cite

show abstract

“…This may consequently lead to an increase in attendance and effectiveness of cervical cancer screening ( Tranberg et al, 2020 ). Especially urine collection looks promising as it has been reported as the most preferred sampling method for cervical cancer screening in several studies ( Leeman et al, 2017 , Ørnskov et al, 2021 , Rohner et al, 2020 , Sargent et al, 2019 , Tranberg et al, 2020 ). However, urine collection methods differ in these studies and few studies have compared the collection of complete urine void without special devices to cervicovaginal self-sampling in a home-based setting ( Leeman et al, 2017 , Ørnskov et al, 2021 , Rohner et al, 2020 , Sargent et al, 2019 , Tranberg et al, 2020 ).…”

Section: Introductionmentioning

confidence: 99%

Experiences and preferences towards collecting a urine and cervicovaginal self-sample among women attending a colposcopy clinic

Schaafsma

Helder

Bleeker

et al. 2022

Preventive Medicine Reports

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“…High correlates between urinary HPV DNA and cervical infections have been established and studies have confirmed the presence of HPV specific antibodies in FV urine [ 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 ]. Urine is considered the preferred choice of self-sampling compared to the currently available self-sampling methods used for screening; brush, lavage, spatula, swab and tampon [ 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 ]. Especially during the current COVID-19 (Coronavirus Disease 2019) pandemic, at-home self-sampling will provide a more accessible means for screening or follow-up than attending health care facilities.…”

Section: Introductionmentioning

confidence: 99%

Impact of Collection Volume and DNA Extraction Method on the Detection of Biomarkers and HPV DNA in First-Void Urine

et al. 2021

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The potential of first-void (FV) urine as a non-invasive liquid biopsy for detection of human papillomavirus (HPV) DNA and other biomarkers has been increasingly recognized over the past decade. In this study, we investigated whether the volume of this initial urine stream has an impact on the analytical performance of biomarkers. In parallel, we evaluated different DNA extraction protocols and introduced an internal control in the urine preservative. Twenty-five women, diagnosed with high-risk HPV, provided three home-collected FV urine samples using three FV urine collection devices (Colli-Pee) with collector tubes that differ in volume (4, 10, 20 mL). Each collector tube was prefilled with Urine Conservation Medium spiked with phocine herpesvirus 1 (PhHV-1) DNA as internal control. Five different DNA extraction protocols were compared, followed by PCR for GAPDH and PhHV-1 (qPCR), HPV DNA, and HBB (HPV-Risk Assay), and ACTB (methylation-specific qPCR). Results showed limited effects of collection volume on human and HPV DNA endpoints. In contrast, significant variations in yield for human endpoints were observed for different DNA extraction methods (p < 0.05). Additionally, the potential of PhHV-1 as internal control to monitor FV urine collection, storage, and processing was demonstrated.

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Racial and Ethnic Differences in Acceptability of Urine and Cervico-Vaginal Sample Self-Collection for HPV-Based Cervical Cancer Screening

Cited by 21 publications

References 35 publications

Clinical and analytical evaluation of the RealTime High Risk HPV assay in Colli-Pee collected first-void urine using the VALHUDES protocol

Clinical and analytical evaluation of the RealTime High Risk HPV assay in Colli-Pee collected first-void urine using the VALHUDES protocol

Experiences and preferences towards collecting a urine and cervicovaginal self-sample among women attending a colposcopy clinic

Impact of Collection Volume and DNA Extraction Method on the Detection of Biomarkers and HPV DNA in First-Void Urine

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