Cross-sectional study of HPV testing in self-sampled urine and comparison with matched vaginal and cervical samples in women attending colposcopy for the management of abnormal cervical screening
Open accessAbstract
Objectives: Human 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. Design: Cross-sectional study. Setting: Secondary care colposcopy clinic in North West England. Participants: Women 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 RealTi me (ART) and Roche Cobas 4800 (RC), respectively. Intervention: Self-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 measure: The sensitivity of urine to detect underlying CIN2+. Secondary outcome measures: The comparative sensitivity of vaginal and cervical samples to detect CIN2+; the acceptability of urine sampling. Results: Preservative-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. Conclusions: Urinary HR-HPV detection offers an alternative strategy of cervical screening. Larger studies to determine its clinical utility are warranted.
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The study supports the conclusion that manufacturer's Cq cutoffs for positivity in HPV assays should always be handled with caution, especially when performing research within different age categories, socioeconomic settings, or types of (self-)sampling.
“our study supports the assumption of other previous studies which concluded that the, often for specific circumstances validated and optimized, manufacturer’s Cq cutoffs for positivity in HPV assays should always be handled with caution, especially when performing research within different age categories (23), socioeconomic”
From Comparison between the Roche Cobas 4800 Human Papillomavirus (HPV), Abbott RealTime High-Risk HPV, Seegene Anyplex II HPV28, and Novel Seegene Allplex HPV28 Assays for High-Risk HPV Detection and Genotyping in Mocked Self-Samples (2023) · cites this paper as [25]
The Discussion (page unavailable) says more work is needed to define clinically useful viral-load thresholds for urine testing, which supports some caution when applying assay thresholds to a different sample type. But it also says the manufacturer’s cut-offs appeared appropriate for the urine samples studied. The paper does not assess whether cut-offs require particular caution across age categories or socioeconomic settings, so it does not support the claim’s broader conclusion. (LLM, conf=0.82)
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Ronco, G., Dillner, J., Elfström, K. M., Tunesi, S., Snijders, P. J. F., Arbyn, M., Kitchener, H., Segnan, N., Gilham, C., Giorgi-Rossi, P., et al. (2014) · The Lancet · doi:10.1016/s0140-6736(13)62218-7 · Cited by 1,810 · see citing works
Self-citationPrice, M. J., Ades, A., Soldan, K., Welton, N. J., Macleod, J., Simms, I., DeAngelis, D., Turner, K. M., & Horner, P. J. (2016) · Health Technology Assessment · doi:10.3310/hta20220 · Cited by 494 · see citing works
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Research works printed but not linked: 18
- [1]Crosbie EJ, Einstein MH, Franceschi S, et al Human papillomavirus and cervical cancer. Lancet 2013; 382: 889– 99. 10.1016/S0140-6736(13)60022-7 23618600 · DOI
- [2]Kitchener HC, Denton K, Soldan K, et al Developing role of HPV in cervical cancer prevention. BMJ 2013; 347: f4781 10.1136/bmj.f4781 23926316 · DOI
- [4]Waller J, Bartoszek M, Marlow L, et al Barriers to cervical cancer screening attendance in England: a population-based survey. J Med Screen 2009; 16: 199– 204. 10.1258/jms.2009.009073 20054095 · DOI · Paper page
- [5]Kitchener HC, Gittins M, Rivero-Arias O, et al A cluster randomised trial of strategies to increase cervical screening uptake at first invitation (STRATEGIC). Health Technol Assess 2016; 20: 1– 138. 10.3310/hta20680 PMC5046076 27632816 · DOI
- [6]Verdoodt F, Jentschke M, Hillemanns P, et al Reaching women who do not participate in the regular cervical cancer screening programme by offering self-sampling kits: a systematic review and meta-analysis of randomised trials. Eur J Cancer 2015; 51: 2375– 85. 10.1016/j.ejca.2015.07.006 26296294 · DOI · Paper page
- [7]Polman NJ, Ebisch RMF, Heideman DAM, et al Performance of human papillomavirus testing on self-collected versus clinician-collected samples for the detection of cervical intraepithelial neoplasia of grade 2 or worse: a randomised, paired screen-positive, non-inferiority trial. Lancet Oncol 2019; 20: 229– 38. 10.1016/S1470-2045(18)30763-0 30658933 · DOI
- [8]Stanczuk G, Baxter G, Currie H, et al Clinical validation of hrHPV testing on vaginal and urine self-samples in primary cervical screening (cross-sectional results from the Papillomavirus Dumfries and Galloway-PaVDaG study). BMJ Open 2016; 6: e010660 10.1136/bmjopen-2015-010660 PMC4854001 27113237 · DOI
- [9]Pathak N, Dodds J, Zamora J, et al Accuracy of urinary human papillomavirus testing for presence of cervical HPV: systematic review and meta-analysis. BMJ 2014; 349: g5264 10.1136/bmj.g5264 25232064 PMC4166201 · DOI
- [10]Kitchener HC, Owens GL Urine Testing for HPV. A promising screening option that deserves further evaluation. BMJ 2014; 349: g5542. 25230583
- [11]Blake DA, Crosbie EJ, Kitson S Urinary HPV testing may offer hope for cervical screening non-attenders. BJOG 2017 124: 1364 10.1111/1471-0528.14683 28391626 · DOI
- [12]Johnson DJ, Calderaro AC, Roberts KA Variation in nuclear DNA concentrations during urination. J Forensic Sci 2007; 52: 110– 3. 10.1111/j.1556-4029.2006.00329.x 17209920 · DOI
- [13]Vorsters A, Van den Bergh J, Micalessi I, et al Optimization of HPV DNA detection in urine by improving collection, storage, and extraction. Eur J Clin Microbiol Infect Dis 2014; 33: 2005– 14. 10.1007/s10096-014-2147-2 24916950 · DOI
- [14]Heideman DA, Hesselink AT, Berkhof J, et al Clinical validation of the cobas 4800 HPV test for cervical screening purposes. J Clin Microbiol 2011; 49: 3983– 5. 10.1128/JCM.05552-11 21880968 PMC3209101 · DOI
- [15]Poljak M, Ostrbenk A, Seme K, et al Comparison of clinical and analytical performance of the Abbott Realtime High Risk HPV test to the performance of hybrid capture 2 in population-based cervical cancer screening. J Clin Microbiol 2011; 49: 1721– 9. 10.1128/JCM.00012-11 21430098 PMC3122641 · DOI
- [16]Moss SM, Bailey A, Cubie H, et al Comparison of the performance of HPV tests in women with abnormal cytology: results of a study within the NHS cervical screening programme. Cytopathology 2015; 26: 373– 80. 10.1111/cyt.12210 25274541 · DOI
- [17]Daponte A, Pournaras S, Mademtzis I, et al Evaluation of high-risk human papillomavirus types PCR detection in paired urine and cervical samples of women with abnormal cytology. J Clin Virol 2006; 36: 189– 93. 10.1016/j.jcv.2006.03.009 16690350 · DOI
- [18]Daponte A, Tsezou A, Oikonomou P, et al Use of real-time PCR to detect human papillomavirus-16 viral loads in vaginal and urine self-sampled specimens. Clin Microbiol Infect 2008; 14: 619– 21. 10.1111/j.1469-0691.2008.01974.x 18384392 · DOI
- [19]Szarewski A, Cadman L, Mesher D, et al HPV self-sampling as an alternative strategy in non-attenders for cervical screening - a randomised controlled trial. Br J Cancer 2011; 104: 915– 20. 10.1038/bjc.2011.48 21343937 PMC3065284 · DOI
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Bouvard, V., Wentzensen, N., Mackie, A., Berkhof, J., Brotherton, J., Giorgi-Rossi, P., Kupets, R., Smith, R., Arrossi, S., Bendahhou, K., et al. (2021) · New England Journal of Medicine · doi:10.1056/nejmsr2030640 · Cited by 357 · see citing works
Bell, M., Verberckmoes, B., Devolder, J., Vermandere, H., Degomme, O., Guimarães, Y. M., Godoy, L. R., Ambrosino, E., Cools, P., & Padalko, E. (2023) · Microbiology Spectrum · doi:10.1128/spectrum.00081-23 · Cited by 22 · see citing works
- Authors
- Sargent, A., Fletcher, S., Bray, K., Kitchener, H. C., & Crosbie, E. J.
- Affiliations
- Clinical Virology Department, Manchester Royal Infirmary, Manchester University NHS Foundation Trust, Manchester, UK
- University of Manchester (GB)
- Manchester Academic Health Science Centre (GB)
- Corresponding author
- Crosbie, Emma J
- Venue
- BMJ Open
- Publisher
- BMJ
- Published
- 2019-04
- Volume
- 9
- Issue
- 4
- Pages
- e025388
- ISSN
- 2044-6055 (ISSN-L)
- PMC
- PMC6502061
- OpenAlex
- W2940613756
- Cited by
- 75
- References
- 2
- Citations by year
- 2026: 3 · 2025: 11 · 2024: 11 · 2023: 14 · 2022: 10 · 2021: 19 · 2020: 6 · 2019: 1
- FWCI
- 6.85
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by-nc
- Locations
- BMJ Open (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Research Explorer (The University of Manchester) (acceptedVersion, cc-by-nc)
- HighWire Press Open Archive (submittedVersion)
- Funders
- Research Trainees Coordinating Centre
- Topics
- Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Women's cancer prevention and management
- Life Sciences › Immunology and Microbiology › Microbiology › Reproductive tract infections research
- Keywords
- human papillomavirus, urine-based HPV testing, self-sampling, cervical cancer screening, cervical intraepithelial neoplasia, CIN2+ detection, vaginal samples, test sensitivity, colposcopy, non-attenders
- MeSH terms
- Adult, Uterine Cervical Dysplasia, Uterine Cervical Neoplasms, Cross-Sectional Studies, Female, Humans, Mass Screening, Middle Aged, Sensitivity and Specificity, Papillomaviridae, Papillomavirus Infections, Early Detection of Cancer
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