{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,19]],"date-time":"2026-06-19T16:15:58Z","timestamp":1781885758055,"version":"3.54.5"},"reference-count":30,"publisher":"American Society for Microbiology","issue":"9","license":[{"start":{"date-parts":[[2025,9,2]],"date-time":"2025-09-02T00:00:00Z","timestamp":1756771200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,9,2]],"date-time":"2025-09-02T00:00:00Z","timestamp":1756771200000},"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":["Microbiol Spectr"],"published-print":{"date-parts":[[2025,9,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:sec>\n            <jats:title\/>\n            <jats:p>Primary high-risk human papillomavirus (HPV) testing is recommended for cervical cancer screening due to its sensitivity and high negative predictive value. Most of the cervical cancers are caused by HPV16 and HPV18, and their presence has been used to guide patient management. Here, we compared the clinical performance of the Alinity m HR HPV, cobas 4800 HPV, and cobas 6800 HPV assays in the context of cervical cancer screening. Clinical sensitivity and specificity were evaluated with 125 \u2265CIN3 (cervical intraepithelial neoplasia grade 3) cases and 244 controls (\u2264CIN1). The genotype agreements between the assays were also evaluated for the case and control groups. The clinical sensitivities were 96.0% for Alinity m and cobas 6800 assays, and 95.2% for cobas 4800 assay. The clinical specificities observed were 67.6%, 68.0%, and 68.4% for Alinity m, cobas 6800, and cobas 4800 assays, respectively. Overall, the three HPV assays demonstrated similar clinical performance. In the \u2265CIN3 group, genotype-specific positive agreement was \u226598.4% between Alinity m and cobas 4800 assays, and \u226585.7% between cobas 6800 and cobas 4800 assays. In the \u2264CIN1 group, overall positive agreement among the three assays was \u226594.8%. This study showed similar clinical sensitivity and specificity for Alinity m HR HPV, cobas 4800 HPV, and cobas 6800 HPV assays. Alinity m was more specific in detecting HPV16 and HPV18, which could reduce unnecessary immediate referrals of women to colposcopy.<\/jats:p>\n            <jats:sec>\n              <jats:title>IMPORTANCE<\/jats:title>\n              <jats:p>This study provides evidence that the Alinity m HR human papillomavirus (HPV) assay has similar clinical performance in comparison with the cobas 4800 HPV and cobas 6800 HPV, two widely used tests. Validation of HPV assays in a clinical setting is crucial to ensure that they can provide a balanced sensitivity and specificity for detecting high-grade cervical intraepithelial neoplasia, potentially improving patient management by enabling proper follow-up or treatment and avoiding unnecessary procedures.<\/jats:p>\n            <\/jats:sec>\n          <\/jats:sec>","DOI":"10.1128\/spectrum.00589-25","type":"journal-article","created":{"date-parts":[[2025,8,6]],"date-time":"2025-08-06T13:01:31Z","timestamp":1754485291000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":2,"title":["Comparative clinical performance of Alinity m HR HPV, cobas 4800 HPV, and cobas 6800 HPV for cervical cancer screening"],"prefix":"10.1128","volume":"13","author":[{"given":"Shihai","family":"Huang","sequence":"first","affiliation":[{"name":"Molecular Diagnostics of Abbott","place":["Des Plaines, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1530-6809","authenticated-orcid":true,"given":"Luciana Girotto","family":"Gentil","sequence":"additional","affiliation":[{"name":"Abbott Laboratories de Chile Ltda.","place":["Santiago, Chile"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Colleen","family":"Schmidt","sequence":"additional","affiliation":[{"name":"Molecular Diagnostics of Abbott","place":["Des Plaines, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Cullum","sequence":"additional","affiliation":[{"name":"Molecular Diagnostics of Abbott","place":["Des Plaines, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan","family":"Zhang","sequence":"additional","affiliation":[{"name":"Molecular Diagnostics of Abbott","place":["Des Plaines, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Nelson","sequence":"additional","affiliation":[{"name":"Molecular Diagnostics of Abbott","place":["Des Plaines, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danijela","family":"Lucic","sequence":"additional","affiliation":[{"name":"Molecular Diagnostics of Abbott","place":["Des Plaines, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Klara","family":"Abravaya","sequence":"additional","affiliation":[{"name":"Molecular Diagnostics of Abbott","place":["Des Plaines, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.currproblcancer.2018.06.013"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.g130"},{"key":"e_1_3_3_4_2","unstructured":"USPSTF. 2018 USPSTF recommendation: cervical cancer: screening on United States preventive services taskforce. Available from: https:\/\/www.uspreventiveservicestaskforce.org\/uspstf\/recommendation\/cervical-cancer-screening#fullrecommendationstart"},{"key":"e_1_3_3_5_2","unstructured":"ACOG. 2024. Updated cervical cancer screening guidelines on American college of obstetricians and gynecologists. Available from: https:\/\/www.acog.org\/clinical\/clinical-guidance\/practice-advisory\/articles\/2021\/04\/updated-cervical-cancer-screening-guidelines"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21628"},{"key":"e_1_3_3_7_2","volume-title":"Cervical cancer screening: IARC handbooks of cancer prevention","author":"IARC","year":"2022","unstructured":"IARC. 2022. Cervical cancer screening: IARC handbooks of cancer prevention. Vol. 18. IARC Publications."},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1136\/gocm-2024-000005"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(10)70230-8"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.eclinm.2020.100293"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2024.105671"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.24010"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1002\/jmv.29881"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.05552-11"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01120-19"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01239-18"},{"key":"e_1_3_3_17_2","unstructured":"Molecular A. 2023. HR HPV AMP Kit package insert. Ref 09N15-095 (53-608175\/R1). Des Plaines IL USA Abbott Molecular Inc"},{"key":"e_1_3_3_18_2","unstructured":"Molecular R. 2015. cobas HPV test package insert. 05641268001-12EN Doc Rev. 12.0. Branchburg NJ Roche Molecular Systems Inc"},{"key":"e_1_3_3_19_2","unstructured":"Molecular R. 2020. cobas HPV for use on the cobas 6800\/8800 Systems (cobas HPV) package insert. 07998031001-01EN Doc Rev. 1.0. Branchburg NJ Roche Molecular Systems Inc"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1097\/LGT.0000000000000900"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-319-11074-5"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12905-019-0743-0"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00286-21"},{"key":"e_1_3_3_24_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2021.104851"},{"key":"e_1_3_3_25_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0247291"},{"key":"e_1_3_3_26_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-024-71735-2"},{"key":"e_1_3_3_27_2","unstructured":"ASCCP. 2024. Enduring guidelines extended genotyping evidence summary and proposed recommendations. Available from: https:\/\/www.asccp.org\/Assets\/80742b9b-2b64-4140-a81c-981eaab5ee26\/638467215678330000\/enduring-guidelines-extended-genotyping-summary-032224-pdf"},{"key":"e_1_3_3_28_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(24)01097-3"},{"key":"e_1_3_3_29_2","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.25408"},{"key":"e_1_3_3_30_2","doi-asserted-by":"publisher","DOI":"10.1158\/1055-9965.EPI-10-0424"},{"key":"e_1_3_3_31_2","doi-asserted-by":"publisher","DOI":"10.1093\/ajcp\/aqy169"}],"container-title":["Microbiology Spectrum"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.00589-25","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.00589-25","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,2]],"date-time":"2025-09-02T13:03:50Z","timestamp":1756818230000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/spectrum.00589-25"}},"subtitle":[],"editor":[{"given":"Meghan","family":"Starolis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2025,9,2]]},"references-count":30,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2025,9,2]]}},"alternative-id":["10.1128\/spectrum.00589-25"],"URL":"https:\/\/doi.org\/10.1128\/spectrum.00589-25","relation":{},"ISSN":["2165-0497"],"issn-type":[{"value":"2165-0497","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9,2]]},"assertion":[{"value":"2025-02-28","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-07-09","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-08-06","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e00589-25"}}