Urine high-risk human papillomavirus testing as an alternative to routine cervical screening: A comparative diagnostic accuracy study of two urine collection devices using a randomised study design trial

IF 5.4 3区材料科学 Q2 CHEMISTRY, PHYSICAL

ACS Applied Energy Materials Pub Date : 2024-04-25 DOI:10.1111/1471-0528.17831

Jennifer C. Davies, Alexandra Sargent, Elisabeth Pinggera, Suzanne Carter, Clare Gilham, Peter Sasieni, Emma J. Crosbie

{"title":"Urine high-risk human papillomavirus testing as an alternative to routine cervical screening: A comparative diagnostic accuracy study of two urine collection devices using a randomised study design trial","authors":"Jennifer C. Davies, Alexandra Sargent, Elisabeth Pinggera, Suzanne Carter, Clare Gilham, Peter Sasieni, Emma J. Crosbie","doi":"10.1111/1471-0528.17831","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Objective</h3>\n \n <p>To evaluate the sensitivity of human papillomavirus (HPV) tested urine to detect high-grade cervical precancer (cervical intraepithelial neoplasia grade 2+ [CIN2+]) using two urine collection devices.</p>\n </section>\n \n <section>\n \n <h3> Design</h3>\n \n <p>Randomised controlled trial.</p>\n </section>\n \n <section>\n \n <h3> Setting</h3>\n \n <p>St Mary's Hospital, Manchester, UK.</p>\n </section>\n \n <section>\n \n <h3> Population</h3>\n \n <p>Colposcopy attendees with abnormal cervical screening; a total of 480 participants were randomised. Matched urine and cervical samples were available for 235 and 230 participants using a first-void urine (FVU)-collection device and standard pot, respectively.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>Urine was self-collected and mixed with preservative – randomised 1:1 to FVU-collection device (Novosanis Colli-pee® 10 mL with urine conservation medium [UCM]) or standard pot. Matched clinician-collected cervical samples were taken before colposcopy. HPV testing used Roche cobas® 8800. A questionnaire evaluated urine self-sampling acceptability.</p>\n </section>\n \n <section>\n \n <h3> Main outcome measures</h3>\n \n <p>The primary outcome measured sensitivity of HPV-tested urine (FVU-collection device and standard pot) for CIN2+ detection. Secondary outcomes compared HPV-tested cervical and urine samples for CIN2+ and evaluated the acceptability of urine self-sampling.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Urine HPV test sensitivity for CIN2+ was higher with the FVU-collection device (90.3%, 95% CI 83.7%–94.9%, 112/124) than the standard pot (73.4%, 95% CI 64.7%–80.9%, 91/124, <i>p</i> = 0.0005). The relative sensitivity of FVU-device-collected urine was 0.92 (95% CI 0.87–0.97, <i>p</i><sub>McN</sub> = 0.004) compared with cervical, considering that all women were referred after a positive cervical HPV test. Urine-based sampling was acceptable to colposcopy attendees.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>Testing of FVU-device-collected urine for HPV was superior to standard-pot-collected urine in colposcopy attendees and has promising sensitivity for CIN2+ detection. General population HPV testing of FVU-device-collected urine will establish its clinical performance and acceptability as an alternative to routine cervical screening.</p>\n </section>\n </div>","PeriodicalId":4,"journal":{"name":"ACS Applied Energy Materials","volume":"131 11","pages":"1456-1464"},"PeriodicalIF":5.4000,"publicationDate":"2024-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/1471-0528.17831","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"ACS Applied Energy Materials","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/1471-0528.17831","RegionNum":3,"RegionCategory":"材料科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CHEMISTRY, PHYSICAL","Score":null,"Total":0}

引用次数: 0

Abstract

Objective

To evaluate the sensitivity of human papillomavirus (HPV) tested urine to detect high-grade cervical precancer (cervical intraepithelial neoplasia grade 2+ [CIN2+]) using two urine collection devices.

Design

Randomised controlled trial.

Setting

St Mary's Hospital, Manchester, UK.

Population

Colposcopy attendees with abnormal cervical screening; a total of 480 participants were randomised. Matched urine and cervical samples were available for 235 and 230 participants using a first-void urine (FVU)-collection device and standard pot, respectively.

Methods

Urine was self-collected and mixed with preservative – randomised 1:1 to FVU-collection device (Novosanis Colli-pee® 10 mL with urine conservation medium [UCM]) or standard pot. Matched clinician-collected cervical samples were taken before colposcopy. HPV testing used Roche cobas® 8800. A questionnaire evaluated urine self-sampling acceptability.

Main outcome measures

The primary outcome measured sensitivity of HPV-tested urine (FVU-collection device and standard pot) for CIN2+ detection. Secondary outcomes compared HPV-tested cervical and urine samples for CIN2+ and evaluated the acceptability of urine self-sampling.

Results

Urine HPV test sensitivity for CIN2+ was higher with the FVU-collection device (90.3%, 95% CI 83.7%–94.9%, 112/124) than the standard pot (73.4%, 95% CI 64.7%–80.9%, 91/124, p = 0.0005). The relative sensitivity of FVU-device-collected urine was 0.92 (95% CI 0.87–0.97, p_McN = 0.004) compared with cervical, considering that all women were referred after a positive cervical HPV test. Urine-based sampling was acceptable to colposcopy attendees.

Conclusions

Testing of FVU-device-collected urine for HPV was superior to standard-pot-collected urine in colposcopy attendees and has promising sensitivity for CIN2+ detection. General population HPV testing of FVU-device-collected urine will establish its clinical performance and acceptability as an alternative to routine cervical screening.

Abstract Image

查看原文本刊更多论文

尿液高危人类乳头瘤病毒检测作为常规宫颈筛查的替代方法：采用随机研究设计试验对两种尿液收集装置的诊断准确性进行比较研究

目的：评估使用两种尿液收集装置检测尿液中人类乳头瘤病毒（HPV）对高级别宫颈癌前病变（宫颈上皮内瘤变 2+ 级 [CIN2+]）的敏感性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

ACS Applied Energy Materials Materials Science-Materials Chemistry

CiteScore

10.30

自引率

6.20%

发文量

1368

期刊介绍： ACS Applied Energy Materials is an interdisciplinary journal publishing original research covering all aspects of materials, engineering, chemistry, physics and biology relevant to energy conversion and storage. The journal is devoted to reports of new and original experimental and theoretical research of an applied nature that integrate knowledge in the areas of materials, engineering, physics, bioscience, and chemistry into important energy applications.