{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T18:37:04Z","timestamp":1783363024466,"version":"3.54.6"},"reference-count":27,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2012,9,17]],"date-time":"2012-09-17T00:00:00Z","timestamp":1347840000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancer Cytopathology"],"published-print":{"date-parts":[[2013,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>BACKGROUND:<\/jats:title><jats:p>The objective of the current study was to investigate the clinical performance of detecting high\u2010grade lesions with the CINtec PLUS p16<jats:sup>INK4a<\/jats:sup>\/Ki\u201067 dual stain and the APTIMA human papillomavirus (HPV) Assay in a cohort of women with low\u2010grade squamous intraepithelial lesion (LSIL) cytology. The authors also assessed the reproducibility of the evaluation of immunocytochemical staining.<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS:<\/jats:title><jats:p>The 2 tests were performed on liquid\u2010based residual material from 469 women with LSILs. The samples had at least 5 years of follow\u2010up and the gold standard used was high\u2010grade cervical intraepithelial neoplasia (CIN2+\/CIN3+) proven on histology.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS:<\/jats:title><jats:p>Approximately 69% of all the women included in the study had a positive test for HPV mRNA and 56% was positive for the dual stain. The 2 tests demonstrated high sensitivities. When examining the specificities, the APTIMA HPV Assay performed with significantly lower values than the CINtec PLUS test. For patients with CIN2+, the APTIMA HPV Assay had a specificity of 36.1% versus 51.3% for the CINtec PLUS test, and for women with CIN3+, the specificity was 33.8% versus 48.2%, respectively. The difference was even more pronounced when analyzing women aged &lt; 30 years separately. The kappa values between the 3 observers in scoring the dual stain ranged from 0.43 to 0.49 and improved in a second evaluation round to values ranging from 0.50 to 0.66.<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS:<\/jats:title><jats:p>The CINtec PLUS p16<jats:sup>INK4a<\/jats:sup>\/Ki\u201067 dual\u2010staining test in LSIL cytology samples demonstrated high sensitivity that was similar to that of the APTIMA HPV Assay in the detection of underlying high\u2010grade disease but with enhanced specificity, especially among women aged &lt; 30 years. The kappa value for the evaluation of the CINtec PLUS dual\u2010staining test was moderate but could be improved through training. Cancer (Cancer Cytopathol) 2013. \u00a9 2012 American Cancer Society.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cncy.21233","type":"journal-article","created":{"date-parts":[[2012,9,17]],"date-time":"2012-09-17T12:26:08Z","timestamp":1347884768000},"page":"136-145","source":"Crossref","is-referenced-by-count":68,"title":["Evaluation of p16<sup>INK4a<\/sup>\/Ki\u201067 dual stain in comparison with an mRNA human papillomavirus test on liquid\u2010based cytology samples with low\u2010grade squamous intraepithelial lesion"],"prefix":"10.1002","volume":"121","author":[{"given":"Marianne","family":"Waldstr\u00f8m","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rikke 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