{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T14:38:21Z","timestamp":1786977501109,"version":"build-2736575974"},"reference-count":29,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2020,2,12]],"date-time":"2020-02-12T00:00:00Z","timestamp":1581465600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100004726","name":"Ministry of Health","doi-asserted-by":"publisher","award":["RF\u20102009\u20101536040"],"award-info":[{"award-number":["RF\u20102009\u20101536040"]}],"id":[{"id":"10.13039\/501100004726","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":[[2020,5]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>p16\/Ki\u201067 dual staining is a candidate biomarker for triaging human papillomavirus (HPV)\u2013positive women. Reproducibility is needed for adopting a test for screening. This study assessed interlaboratory reproducibility in HPV\u2010positive women.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>All women positive for HPV from the Italian New Technologies for Cervical Cancer 2 study,\u00a0were included in this study. ThinPrep slides were immunostained for p16\/Ki\u201067 in 4 laboratories and were interpreted in 7 laboratories. Each slide had 3 reports from different laboratories. Slides were classified as valuable or inadequate, and valuable slides were classified as positive (at least 1 double\u2010stained cell) or negative. Interlaboratory reproducibility was evaluated with \u03ba values.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Overall, we obtained 9300 reports for 3100 cases; 905 reports (9.7%) were inadequate. The overall adequacy concordance was poor (\u03ba\u00a0=\u00a00.224; 95% confidence interval [CI], 0.183\u20100.263). The overall positivity concordance was moderate (\u03ba\u00a0=\u00a00.583; 95% CI, 0.556\u20100.610). Of the 176 cervical intraepithelial neoplasia 2+ (CIN\u20102+) lesions found in HPV DNA\u2013positive women, 158 had a valid result: 107 were positive in all 3 reports (sensitivity for CIN\u20102+, 67.7%; 95% CI, 59.8%\u201074.9%), 23 were positive in 2 reports (sensitivity of the majority report, 82.3%; 95% CI, 75.4%\u201087.9%), and 15 were positive in 1 report (sensitivity of at least 1 positive result, 91.8%; 95% CI, 86.3%\u201095.5%). Thirteen CIN\u20102+ cases were negative in all 3 reports. The overall positivity concordance in CIN\u20102+ samples was \u03ba\u00a0=\u00a00.487 (95% CI, 0.429\u20100.534), whereas in the non\u2013CIN\u20102+ samples, it was \u03ba\u00a0=\u00a00.558 (95% CI, 0.528\u20100.588).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The p16\/Ki\u201067 assay showed poor reproducibility for adequacy and good reproducibility for positivity comparable to that of cervical cytology. Nevertheless, the low reproducibility does not affect the sensitivity for CIN\u20102+.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/cncy.22248","type":"journal-article","created":{"date-parts":[[2020,2,12]],"date-time":"2020-02-12T09:30:05Z","timestamp":1581499805000},"page":"323-332","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Interlaboratory concordance of p16\/Ki\u201067 dual\u2010staining interpretation in HPV\u2010positive women in a screening population"],"prefix":"10.1002","volume":"128","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1994-0935","authenticated-orcid":false,"given":"Maria","family":"Benevolo","sequence":"first","affiliation":[{"name":"Pathology Department IRCCS Regina Elena National Cancer Institute Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1609-2440","authenticated-orcid":false,"given":"Pamela","family":"Mancuso","sequence":"additional","affiliation":[{"name":"Epidemiology Unit, Azienda Unit\u00e0 Sanitaria Locale\u2013IRCCS of Reggio Emilia Reggio Emilia Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Allia","sequence":"additional","affiliation":[{"name":"Centre for Cervical Cancer Screening, City of Health and Science Hospital Turin Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniela","family":"Gustinucci","sequence":"additional","affiliation":[{"name":"Laboratory Screening Unit, Local Health Authority\u2010Umbria 1 Perugia Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simonetta","family":"Bulletti","sequence":"additional","affiliation":[{"name":"Laboratory Screening Unit, Local Health Authority\u2010Umbria 1 Perugia Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Cesarini","sequence":"additional","affiliation":[{"name":"Laboratory Screening Unit, Local Health Authority\u2010Umbria 1 Perugia Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca Maria","family":"Carozzi","sequence":"additional","affiliation":[{"name":"Regional Laboratory of Cancer Prevention Institute for Cancer Research, Prevention and Clinical Network (ISPRO) Florence Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Massimo","family":"Confortini","sequence":"additional","affiliation":[{"name":"Regional Laboratory of Cancer Prevention Institute for Cancer Research, Prevention and Clinical Network (ISPRO) Florence Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simonetta","family":"Bisanzi","sequence":"additional","affiliation":[{"name":"Regional Laboratory of Cancer Prevention Institute for Cancer Research, Prevention and Clinical Network (ISPRO) Florence Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriele","family":"Carlinfante","sequence":"additional","affiliation":[{"name":"Cervico\u2010Vaginal Cytology Unit, Azienda Unit\u00e0 Sanitaria Locale\u2013IRCCS of Reggio Emilia Reggio Emilia Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teresa","family":"Rubino","sequence":"additional","affiliation":[{"name":"Cervico\u2010Vaginal Cytology Unit, Azienda Unit\u00e0 Sanitaria Locale\u2013IRCCS of Reggio Emilia Reggio Emilia Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Rollo","sequence":"additional","affiliation":[{"name":"Pathology Department IRCCS Regina Elena National Cancer Institute Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natalina","family":"Marchi","sequence":"additional","affiliation":[{"name":"Unit 17, Local Health and Social Care Facility Este\u2010Monselice Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angelo","family":"Farruggio","sequence":"additional","affiliation":[{"name":"Unit 17, Local Health and Social Care Facility Este\u2010Monselice Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teresa","family":"Pusiol","sequence":"additional","affiliation":[{"name":"Screening Cervical Cancer Prevention Laboratory, Institute of Anatomic Pathology, Rovereto Hospital Rovereto Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"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\u2013IRCCS of Reggio Emilia Reggio Emilia Italy"},{"name":"Clinical and Experimental Medicine PhD Program, University of Modena and Reggio Emilia Modena Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"Giorgi Rossi","sequence":"additional","affiliation":[{"name":"Epidemiology Unit, Azienda Unit\u00e0 Sanitaria Locale\u2013IRCCS of Reggio Emilia Reggio Emilia Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the New Technologies for\u00a0Cervical Cancer 2 Working Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,2,12]]},"reference":[{"key":"e_1_2_8_2_1","first-page":"e1","article-title":"Health technology assessment report: HPV DNA based primary screening for cervical cancer precursors","volume":"36","author":"Ronco G","year":"2012","journal-title":"Epidemiol Prev"},{"key":"e_1_2_8_3_1","first-page":"1","volume-title":"European Guidelines for Quality Assurance in Cervical Cancer Screening","author":"Ronco G","year":"2015"},{"key":"e_1_2_8_4_1","volume-title":"European 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