{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,6]],"date-time":"2026-03-06T15:52:44Z","timestamp":1772812364636,"version":"3.50.1"},"reference-count":12,"publisher":"Oxford University Press (OUP)","issue":"2","funder":[{"name":"GeneXpert systems"},{"name":"A.J. Pierz"},{"DOI":"10.13039\/100004337","name":"Roche","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004337","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,3,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Human papillomavirus (HPV) testing is the standard-of-care for cervical cancer screening globally. Urine is a promising alternative to collecting a cervical specimen during a pelvic exam for HPV testing. There are no studies to date of HPV testing of urine using the Xpert HPV test.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We conducted a pilot study of 40 women; 30 women undergoing colposcopy because of a previous abnormality and 10 undergoing routine screening, to evaluate HPV detection in urine by the Xpert HPV test on the GeneXpert platform. Xpert HPV testing of urine was done according to the manufacturer\u2019s instructions for testing cervical specimens. These results were compared to a reference of combined results of 2 research HPV genotyping tests conducted on cervical specimens and to repeat Xpert HPV testing of urine.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Analytic sensitivity and specificity of Xpert testing of urine for any high-risk HPV versus the cervical sample, categorized as HPV positive if at least 1 test was positive, were 64.3% (95% confidence interval [95%CI] \u2009=\u200942.1\u201376.1%) and 100% (97.5%CI\u2009=\u200971.5\u2013100%), respectively. Analytic sensitivity and specificity of Xpert testing of urine for any high-risk HPV versus the cervical sample, categorized as positive if both tests were positive, were 66.7% (95%CI\u2009=\u200944.7\u201384.4%) and 86.7% (95%CI\u2009=\u200959.5\u201398.3%), respectively. Kappa values for first vs. second and first vs. third testing of urine by Xpert were 0.89 (95%CI\u2009=\u20090.79\u20131.00) and 0.90 (95%CI\u2009=\u20090.81\u20131.00), respectively.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Discussion<\/jats:title>\n                  <jats:p>Given the call for global elimination of cervical cancer and widespread availability of GeneXpert, optimizing Xpert HPV testing of urine may be warranted.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jalm\/jfaa238","type":"journal-article","created":{"date-parts":[[2020,12,19]],"date-time":"2020-12-19T08:05:20Z","timestamp":1608365120000},"page":"474-479","source":"Crossref","is-referenced-by-count":10,"title":["A Pilot Study of Human Papillomavirus Detection in Urine Using a Novel Nucleic Acid Amplification Test"],"prefix":"10.1093","volume":"6","author":[{"given":"Jenna Z","family":"Marcus","sequence":"first","affiliation":[{"name":"Rutgers New Jersey Medical School and Cancer Institute of New Jersey (CINJ), Newark, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasmin","family":"Abedin","sequence":"additional","affiliation":[{"name":"Rutgers New Jersey Medical School and Cancer Institute of New Jersey (CINJ), Newark, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amanda J","family":"Pierz","sequence":"additional","affiliation":[{"name":"Albert Einstein College of Medicine, Bronx, NY, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yanille","family":"Taveras","sequence":"additional","affiliation":[{"name":"Rutgers New Jersey Medical School and Cancer Institute of New Jersey (CINJ), Newark, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christopher C","family":"Sollecito","sequence":"additional","affiliation":[{"name":"Albert Einstein College of Medicine, Bronx, NY, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Heta","family":"Parmar","sequence":"additional","affiliation":[{"name":"Rutgers New Jersey Medical School and Cancer Institute of New Jersey (CINJ), Newark, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert D","family":"Burk","sequence":"additional","affiliation":[{"name":"Albert Einstein College of Medicine, Bronx, NY, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Philip E","family":"Castle","sequence":"additional","affiliation":[{"name":"Albert Einstein College of Medicine, Bronx, NY, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2021,2,4]]},"reference":[{"key":"2021030606030996700_jfaa238-B1","doi-asserted-by":"crossref","first-page":"321","DOI":"10.3322\/caac.21628","article-title":"Cervical cancer screening for individuals at average risk: 2020 guideline update from the American Cancer Society","volume":"70","author":"Fontham","year":"2020","journal-title":"CA A Cancer J Clin"},{"key":"2021030606030996700_jfaa238-B2","doi-asserted-by":"crossref","first-page":"635","DOI":"10.1200\/JGO.2016.006577","article-title":"Secondary prevention of cervical cancer: ASCO resource-stratified clinical practice guideline","volume":"3","author":"Jeronimo","year":"2017","journal-title":"J Glob Oncol"},{"key":"2021030606030996700_jfaa238-B3","doi-asserted-by":"crossref","first-page":"674","DOI":"10.1001\/jama.2018.10897","article-title":"Screening for cervical cancer: US Preventive Services Task Force recommendation statement","volume":"320","author":"Curry","year":"2018","journal-title":"JAMA"},{"key":"2021030606030996700_jfaa238-B4","year":"2013"},{"key":"2021030606030996700_jfaa238-B5","doi-asserted-by":"crossref","first-page":"k4823","DOI":"10.1136\/bmj.k4823","article-title":"Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses","volume":"363","author":"Arbyn","year":"2018","journal-title":"BMJ (Clinical Research ed)"},{"key":"2021030606030996700_jfaa238-B6","first-page":"g5264","article-title":"Accuracy of urinary human papillomavirus testing for presence of cervical HPV: systematic review and meta-analysis","volume":"349","author":"Pathak","year":"2014","journal-title":"BMJ (Clinical Research ed)"},{"key":"2021030606030996700_jfaa238-B7","year":"2017"},{"key":"2021030606030996700_jfaa238-B8","doi-asserted-by":"crossref","first-page":"417","DOI":"10.1002\/jmv.10220","article-title":"Comparisons of HPV DNA detection by MY09\/11 PCR methods","volume":"68","author":"Castle","year":"2002","journal-title":"J Med Virol"},{"key":"2021030606030996700_jfaa238-B9","doi-asserted-by":"crossref","first-page":"796","DOI":"10.1309\/AJCP9P2KJSXEKCJB","article-title":"Development and validation of a new HPV genotyping assay based on next-generation sequencing","volume":"141","author":"Yi","year":"2014","journal-title":"Am J Clin Pathol"},{"key":"2021030606030996700_jfaa238-B10","doi-asserted-by":"crossref","first-page":"1048","DOI":"10.1016\/S1470-2045(10)70230-8","article-title":"Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study","volume":"11","author":"de Sanjose","year":"2010","journal-title":"Lancet Oncol"},{"key":"2021030606030996700_jfaa238-B11","doi-asserted-by":"crossref","first-page":"e01443","DOI":"10.1128\/JCM.01443-19","article-title":"Test accuracy of human papillomavirus in urine for detection of cervical intraepithelial neoplasia","volume":"58","author":"Rohner","year":"2020","journal-title":"J Clin Microbiol"},{"key":"2021030606030996700_jfaa238-B12","doi-asserted-by":"crossref","first-page":"426","DOI":"10.1136\/ijgc-2020-001285","article-title":"World Health Organization call for action to eliminate cervical cancer globally","volume":"30","author":"Gultekin","year":"2020","journal-title":"Int J Gynecol Cancer"}],"container-title":["The Journal of Applied Laboratory 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