{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T15:13:20Z","timestamp":1790176400974,"version":"4.1.0"},"reference-count":28,"publisher":"American Society for Microbiology","issue":"5","license":[{"start":{"date-parts":[[2013,5,1]],"date-time":"2013-05-01T00:00:00Z","timestamp":1367366400000},"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":[[2013,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    The cobas human papillomavirus (HPV) test, approved by the FDA in April 2011, is a fully automated assay for the detection of 14 high-risk (hr) HPV genotypes from cervical specimens collected in liquid-based cytology medium using real-time PCR amplification of the L1 gene and TaqMan probes. Results are simultaneously reported as positive or negative for the pooled 12 oncogenic HPV types (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, and -68) from channel 1, with HPV16 and HPV18 genotypes read individually from channels 2 and 3. A fourth channel detects the human \u03b2-globin gene as a control for sample adequacy and assay inhibition. To optimize clinical sensitivity and specificity, cutoff values (cycle thresholds [\n                    <jats:italic>\n                      C\n                      <jats:sub>T<\/jats:sub>\n                    <\/jats:italic>\n                    ]) were established for each channel based on the detection of cervical intraepithelial neoplasia grade 2 (CIN2) or greater (\u2265CIN2). For women aged \u226521 years with cytology results indicating atypical squamous cells of undetermined significance (ASC-US),\n                    <jats:italic>\n                      C\n                      <jats:sub>T<\/jats:sub>\n                    <\/jats:italic>\n                    values provided a sensitivity of 90% (95% confidence interval [CI], 81.5% to 94.8%) for the detection of \u2265CIN2 and a specificity of 70.5% (95% CI, 68.1% to 72.7%). The analytic sensitivity (limit of detection) ranged from 150 to 2,400 copies\/ml, depending on genotype. The analytic specificity, evaluated by comparing the HPV result with a combined comparator of Sanger sequencing and the Qiagen digene HC2 high-risk HPV DNA test (hc2), demonstrated overall positive agreement of 96.3% for 14 hrHPV types in women with ASC-US cytology results who were aged \u226521 years and 86.1% in women with NLIM (negative for intraepithelial neoplasia or malignancy) cytology who were aged \u226530 years. These and other performance validation studies demonstrate that the cobas HPV test is a fully automated and clinically validated robust test.\n                  <\/jats:p>","DOI":"10.1128\/jcm.03386-12","type":"journal-article","created":{"date-parts":[[2013,2,27]],"date-time":"2013-02-27T22:42:38Z","timestamp":1362004958000},"page":"1478-1484","update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":87,"title":["Development and Characterization of the cobas Human Papillomavirus Test"],"prefix":"10.1128","volume":"51","author":[{"given":"Arundhati","family":"Rao","sequence":"first","affiliation":[{"name":"Scott &amp; White Healthcare, Temple, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Young","sequence":"additional","affiliation":[{"name":"TriCore Reference Laboratories, Albuquerque, New Mexico, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henry","family":"Erlich","sequence":"additional","affiliation":[{"name":"Roche Molecular Systems, Pleasanton, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sean","family":"Boyle","sequence":"additional","affiliation":[{"name":"Roche Molecular Systems, Pleasanton, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Krevolin","sequence":"additional","affiliation":[{"name":"Roche Molecular Systems, Pleasanton, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rita","family":"Sun","sequence":"additional","affiliation":[{"name":"Roche Molecular Systems, Pleasanton, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raymond","family":"Apple","sequence":"additional","affiliation":[{"name":"Roche Molecular Systems, Pleasanton, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Behrens","sequence":"additional","affiliation":[{"name":"Roche Molecular Systems, Pleasanton, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2006.05.113"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(07)61450-0"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa073204"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(11)70188-7"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/dji187"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1309\/AJCPTUS5EXAS6DKZ"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1309\/AJCPZ5JY6FCVNMOT"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djq356"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1002\/cncy.21213"},{"key":"e_1_3_3_11_2","volume-title":"cobas 4800 system manual 1.0.","author":"Roche Molecular Diagnostics","year":"2009","unstructured":"Roche Molecular Diagnostics. 2009. cobas 4800 system manual 1.0. Roche Molecular Diagnostics, Pleasanton, CA."},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.88.16.7276"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.24010"},{"key":"e_1_3_3_14_2","unstructured":"Digene Corporation. 2012. Hybrid Capture 2 High-Risk HPV DNA Test package insert. Digene Corporation Gaithersburg MD. http:\/\/www.thehpvtest.com\/\u223c\/media\/5C4BD0982BED4E3788F65B36AF829AAD.ashx."},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2011.07.024"},{"key":"e_1_3_3_16_2","first-page":"2547","volume-title":"ASA section on statistics in epidemiology.","author":"Kondratovich MV","year":"2005","unstructured":"KondratovichMV YousefWA. 2005. Evaluation of accuracy and optimal cutoff of diagnostic devices in the same study, p 2547\u20132551. In ASA section on statistics in epidemiology. Proceedings of the 2005 Joint Statistical Meeting, Biopharmaceutical Section, Minneapolis, MN."},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.38.1.357-361.2000"},{"key":"e_1_3_3_18_2","unstructured":"Roche Molecular Systems Inc. 2011. cobas HPV Test package insert. Roche Molecular Systems Inc. Pleasanton CA. http:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf10\/P100020c.pdf."},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.virol.2004.03.033"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa021641"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(09)70096-8"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(10)70230-8"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.20244"},{"key":"e_1_3_3_24_2","doi-asserted-by":"publisher","DOI":"10.1038\/sj.bjc.6600688"},{"key":"e_1_3_3_25_2","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.22527"},{"key":"e_1_3_3_26_2","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djn444"},{"key":"e_1_3_3_27_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00476-08"},{"key":"e_1_3_3_28_2","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.20076"},{"key":"e_1_3_3_29_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2011.01.008"}],"updated-by":[{"DOI":"10.1128\/jcm.02752-13","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2013,11,15]],"date-time":"2013-11-15T00:00:00Z","timestamp":1384473600000}}],"container-title":["Journal of Clinical Microbiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/JCM.03386-12","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/JCM.03386-12","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,3,5]],"date-time":"2022-03-05T06:35:08Z","timestamp":1646462108000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/JCM.03386-12"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2013,5]]},"references-count":28,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2013,5]]}},"alternative-id":["10.1128\/JCM.03386-12"],"URL":"https:\/\/doi.org\/10.1128\/jcm.03386-12","relation":{},"ISSN":["0095-1137","1098-660X"],"issn-type":[{"value":"0095-1137","type":"print"},{"value":"1098-660X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2013,5]]},"assertion":[{"value":"2012-12-28","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2013-02-22","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2013-04-16","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}