{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,11]],"date-time":"2026-01-11T16:13:19Z","timestamp":1768147999258,"version":"3.49.0"},"reference-count":18,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2020,11,3]],"date-time":"2020-11-03T00:00:00Z","timestamp":1604361600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100003196","name":"Ministero della Salute","doi-asserted-by":"publisher","award":["RF\u20102009\u20101536040"],"award-info":[{"award-number":["RF\u20102009\u20101536040"]}],"id":[{"id":"10.13039\/501100003196","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["acsjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Cytopathology"],"published-print":{"date-parts":[[2021,5]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>The objective of this study was to describe the determinants of adequacy and positivity of the p16\/Ki\u201067 assay in a human papillomavirus (HPV)\u2010positive screening population enrolled within the New Technologies for Cervical Cancer 2 (NTCC2) study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>ThinPrep slides were immunostained for p16\/Ki\u201067; each slide had 3 reports from different laboratories. The authors included population\u2010related, sampling\u2010related\/staining\u2010related, and interpretation\u2010related variables in the analyses. Adequacy and positivity proportions were stratified by variables of interest. Univariate and multivariate logistic models were used to identify determinants of adequacy and positivity.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In total, 3100 consecutive HPV\u2010positive cases were analyzed. Because every slide was interpreted by 3 centers, 9300 reports were obtained, including 905 (9.7%) that were inadequate and 2632 (28.3%) that were positive. The percentage of cases in which all 3 reports were inadequate increased with increasing age of the women and with inadequate cytology. The highest percentage of adequacy in all 3 reports and of cases with all 3 reports positive was observed in specimens from women who had grade \u22652 cervical intraepithelial neoplasia (CIN2+), atypical squamous cells of undetermined significance or more severe (ASC\u2010US+) cytology, or mRNA positivity. The number of inadequate reports was significantly associated with increasing age, inadequate cytology, mRNA negativity, and scant cellularity. A positive p16\/Ki\u201067 report was associated with an ASC\u2010US+ result and with a positive mRNA result in cases both with and without CIN2+ but was associated with an HPV type 16 and\/or 18 infection only in CIN2+ cases. The presence of CIN2+ was strongly associated with dual staining positivity.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The interpretation of p16\/Ki\u201067 results may be influenced by several different variables, all of which are part of the steps in the procedure, and by the characteristics of the screened population.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cncy.22385","type":"journal-article","created":{"date-parts":[[2020,11,3]],"date-time":"2020-11-03T13:32:37Z","timestamp":1604410357000},"page":"383-393","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Determinants of p16\/Ki\u201067 adequacy and positivity in HPV\u2010positive women from a screening population"],"prefix":"10.1002","volume":"129","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1994-0935","authenticated-orcid":false,"given":"Maria","family":"Benevolo","sequence":"first","affiliation":[{"name":"Pathology 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Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Teresa","family":"Rubino","sequence":"additional","affiliation":[{"name":"Cervico\u2010Vaginal Cytology Unit Azienda Unit\u00e0 Sanitaria Locale \u2010 IRCCS of Reggio Emilia Reggio Emilia Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesca","family":"Rollo","sequence":"additional","affiliation":[{"name":"Pathology Department IRCCS Regina Elena National Cancer Institute Rome Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Natalina","family":"Marchi","sequence":"additional","affiliation":[{"name":"Unit 17 Local Health and Social Care Facility Este\u2010Monselice Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Angelo","family":"Farruggio","sequence":"additional","affiliation":[{"name":"Unit 17 Local Health and Social Care Facility Este\u2010Monselice Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Teresa","family":"Pusiol","sequence":"additional","affiliation":[{"name":"Screening Cervical Cancer Prevention Laboratory Institute of Anatomic Pathology Rovereto Hospital Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9190-8668","authenticated-orcid":false,"given":"Francesco","family":"Venturelli","sequence":"additional","affiliation":[{"name":"Epidemiology Unit Azienda Unit\u00e0 Sanitaria Locale \u2010 IRCCS of Reggio Emilia Reggio Emilia Italy"},{"name":"Clinical and Experimental Medicine PhD Program University of Modena and Reggio Emilia Modena Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9703-2460","authenticated-orcid":false,"given":"Paolo","family":"Giorgi Rossi","sequence":"additional","affiliation":[{"name":"Epidemiology Unit Azienda Unit\u00e0 Sanitaria Locale \u2010 IRCCS of Reggio Emilia Reggio Emilia Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"for the New Technologies for Cervical Cancer 2 (NTCC2) Working Group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,11,3]]},"reference":[{"key":"e_1_2_8_2_1","first-page":"1","volume-title":"European Guidelines for Quality Assurance in Cervical Cancer Screening","author":"Ronco 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