{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T09:01:53Z","timestamp":1792141313970,"version":"4.4.0"},"reference-count":33,"publisher":"American Society for Microbiology","issue":"5","license":[{"start":{"date-parts":[[2018,5,1]],"date-time":"2018-05-01T00:00:00Z","timestamp":1525132800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["J Clin Microbiol"],"published-print":{"date-parts":[[2018,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:p>\n            As cervical cancer screening shifts from cytology to human papillomavirus (HPV) testing, a major question is the clinical value of identifying individual HPV types. We aimed to validate Onclarity (Becton Dickinson Diagnostics, Sparks, MD), a nine-channel HPV test recently approved by the FDA, by assessing (i) the association of Onclarity types\/channels with precancer\/cancer; (ii) HPV type\/channel agreement between the results of Onclarity and cobas (Roche Molecular Systems, Pleasanton, CA), another FDA-approved test; and (iii) Onclarity typing for all types\/channels compared to typing results from a research assay (linear array [LA]; Roche). We compared Onclarity to histopathology, cobas, and LA. We tested a stratified random sample (\n            <jats:italic>n<\/jats:italic>\n            = 9,701) of discarded routine clinical specimens that had tested positive by Hybrid Capture 2 (HC2; Qiagen, Germantown, MD). A subset had already been tested by cobas and LA (\n            <jats:italic>n<\/jats:italic>\n            = 1,965). Cervical histopathology was ascertained from electronic health records. Hierarchical Onclarity channels showed a significant linear association with histological severity. Onclarity and cobas had excellent agreement on partial typing of HPV16, HPV18, and the other 12 types as a pool (sample-weighted kappa value of 0.83); cobas was slightly more sensitive for HPV18 and slightly less sensitive for the pooled high-risk types. Typing by Onclarity showed excellent agreement with types and groups of types identified by LA (kappa values from 0.80 for HPV39\/68\/35 to 0.97 for HPV16). Onclarity typing results corresponded well to histopathology and to an already validated HPV DNA test and could provide additional clinical typing if such discrimination is determined to be clinically desirable.\n          <\/jats:p>","DOI":"10.1128\/jcm.01910-17","type":"journal-article","created":{"date-parts":[[2018,3,1]],"date-time":"2018-03-01T12:59:00Z","timestamp":1519909140000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":22,"title":["Validation of a Human Papillomavirus (HPV) DNA Cervical Screening Test That Provides Expanded HPV Typing"],"prefix":"10.1128","volume":"56","author":[{"given":"Maria","family":"Demarco","sequence":"first","affiliation":[{"name":"Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland, USA"},{"name":"University of Maryland School of Public Health, College Park, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivia","family":"Carter-Pokras","sequence":"additional","affiliation":[{"name":"University of Maryland School of Public Health, College Park, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noorie","family":"Hyun","sequence":"additional","affiliation":[{"name":"Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip E.","family":"Castle","sequence":"additional","affiliation":[{"name":"Albert Einstein College of Medicine, Bronx, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xin","family":"He","sequence":"additional","affiliation":[{"name":"University of Maryland School of Public Health, College Park, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cher M.","family":"Dallal","sequence":"additional","affiliation":[{"name":"University of Maryland School of Public Health, College Park, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jie","family":"Chen","sequence":"additional","affiliation":[{"name":"University of Maryland School of Public Health, College Park, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia C.","family":"Gage","sequence":"additional","affiliation":[{"name":"Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Befano","sequence":"additional","affiliation":[{"name":"Information Management Services Inc., Calverton, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara","family":"Fetterman","sequence":"additional","affiliation":[{"name":"Regional Laboratory, Kaiser Permanente Northern California, Berkeley, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Lorey","sequence":"additional","affiliation":[{"name":"Regional Laboratory, Kaiser Permanente Northern California, Berkeley, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nancy","family":"Poitras","sequence":"additional","affiliation":[{"name":"Regional Laboratory, Kaiser Permanente Northern California, Berkeley, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tina R.","family":"Raine-Bennett","sequence":"additional","affiliation":[{"name":"Division of Research, Kaiser Permanente Northern California, Oakland, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Wentzensen","sequence":"additional","affiliation":[{"name":"Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Schiffman","sequence":"additional","affiliation":[{"name":"Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1158\/1055-9965.EPI-12-1406"},{"key":"e_1_3_2_3_2","volume-title":"US Preventive Services Task Force","year":"2017","unstructured":". 2017. Draft recommendation statement. Cervical cancer: screening. US Preventive Services Task Force, US Department of Health and Human Services, Washington, DC. https:\/\/www.uspreventiveservicestaskforce.org\/Page\/Document\/draft-recommendation-statement\/cervical-cancer-screening2."},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0463.2010.02621.x"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2013.10.002"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1586\/eri.10.104"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.30375"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1002\/path.4405"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00824-08"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1309\/BA43HMCAJ26VWQH3"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2014.09.018"},{"key":"e_1_3_2_12_2","first-page":"1394","article-title":"Restricted cross-reactivity of hybrid capture 2 with nononcogenic human papillomavirus types","volume":"11","author":"Castle PE","year":"2002","unstructured":"Castle PE, Schiffman M, Burk RD, Wacholder S, Hildesheim A, Herrero R, Bratti MC, Sherman ME, Lorincz A. 2002. Restricted cross-reactivity of hybrid capture 2 with nononcogenic human papillomavirus types. Cancer Epidemiol Biomarkers Prev 11:1394\u20131399.","journal-title":"Cancer Epidemiol Biomarkers Prev"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.05989-11"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1158\/1055-9965.EPI-14-1353"},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1309\/AJCP53KMHNRDICBL"},{"key":"e_1_3_2_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ygyno.2015.06.040"},{"key":"e_1_3_2_17_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.00550-17"},{"key":"e_1_3_2_18_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00508-16"},{"key":"e_1_3_2_19_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2016.06.015"},{"key":"e_1_3_2_20_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01366-15"},{"key":"e_1_3_2_21_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12879-015-1281-5"},{"key":"e_1_3_2_22_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00246-15"},{"key":"e_1_3_2_23_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2015.09.014"},{"key":"e_1_3_2_24_2","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/dju153"},{"key":"e_1_3_2_25_2","doi-asserted-by":"publisher","DOI":"10.1158\/1055-9965.EPI-11-0206"},{"key":"e_1_3_2_26_2","doi-asserted-by":"publisher","DOI":"10.1158\/1055-9965.EPI-10-1267"},{"key":"e_1_3_2_27_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ygyno.2017.06.003"},{"key":"e_1_3_2_28_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00181-12"},{"key":"e_1_3_2_29_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2010.06.048"},{"key":"e_1_3_2_30_2","doi-asserted-by":"publisher","DOI":"10.1097\/LGT.0b013e3182630c41"},{"key":"e_1_3_2_31_2","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jir049"},{"key":"e_1_3_2_32_2","doi-asserted-by":"publisher","DOI":"10.1158\/0008-5472.CAN-06-1812"},{"key":"e_1_3_2_33_2","doi-asserted-by":"publisher","DOI":"10.1158\/1055-9965.EPI-04-0799"},{"key":"e_1_3_2_34_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(02)09463-1"}],"container-title":["Journal of Clinical Microbiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/JCM.01910-17","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/JCM.01910-17","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,3,5]],"date-time":"2022-03-05T12:59:09Z","timestamp":1646485149000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/JCM.01910-17"}},"subtitle":[],"editor":[{"given":"Andrew B.","family":"Onderdonk","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2018,5]]},"references-count":33,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2018,5]]}},"alternative-id":["10.1128\/JCM.01910-17"],"URL":"https:\/\/doi.org\/10.1128\/jcm.01910-17","relation":{},"ISSN":["0095-1137","1098-660X"],"issn-type":[{"value":"0095-1137","type":"print"},{"value":"1098-660X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,5]]},"assertion":[{"value":"2017-12-08","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-02-26","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-04-25","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e01910-17"}}