{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T13:31:04Z","timestamp":1791379864894,"version":"4.3.3"},"reference-count":24,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2010,5,5]],"date-time":"2010-05-05T00:00:00Z","timestamp":1273017600000},"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":[[2010,6,25]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>BACKGROUND<\/jats:title><jats:p>The primary goal of this study was to compare the clinical performance of an optimized and rigorously controlled immunocytochemical (ICC) assay for p16<jats:sup>INK4a<\/jats:sup> to high\u2010risk (HR) human papillomavirus (HPV) detection by polymerase chain reaction (PCR) as diagnostic adjuncts for cytology specimens from colposcopy patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS:<\/jats:title><jats:p>The study included 403 cervical cytology specimens collected within 3 months of colposcopy. The colposcopic impression and cervical biopsy diagnosis served as the standards for correlation with cytological, p16<jats:sup>INK4a<\/jats:sup>, and HPV data. p16<jats:sup>INK4a<\/jats:sup> was evaluated using an immunoperoxidase\u2010based assay that was linear over 4 logs for the detection of HeLa\u2010spiked positive control cytology specimens, using a threshold for positive test results that was based on receiver operating characteristic curve analysis. HR\u2010HPV was detected by multiplex PCR using genotype\u2010specific primers.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS:<\/jats:title><jats:p>In all combined diagnostic categories (negative for intraepithelial lesion and malignancy, atypical glandular cells, atypical squamous cells of undetermined significance, atypical squamous cells cannot exclude high\u2010grade squamous intraepithelial lesion, low\u2010grade squamous intraepithelial lesion, and high\u2010grade squamous intraepithelial lesion), the p16<jats:sup>INK4a<\/jats:sup> ICC and HR\u2010HPV assays, respectively, had sensitivity of 81.7% and 83.3% (<jats:italic>P<\/jats:italic> = .81) and specificity of 78.1% and 50.9% (<jats:italic>P<\/jats:italic> &lt; .001) for the detection of underlying \u2265grade 2 cervical intraepithelial neoplasia (CIN) lesions on biopsy. Furthermore, the positive predictive value of p16<jats:sup>INK4a<\/jats:sup> ICC was greater than that of HR\u2010HPV for patients with biopsies \u2265CIN\u20102 (41.2% and 24.2%, respectively, <jats:italic>P<\/jats:italic> = .001).<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS:<\/jats:title><jats:p>This p16<jats:sup>INK4a<\/jats:sup> immunocytochemical assay has superior specificity but similar sensitivity to HR\u2010HPV testing to predict underlying high\u2010grade dysplastic lesions in patients who are referred for colposcopy. The determination of the overall performance characteristics of p16<jats:sup>INK4a<\/jats:sup> immunocytochemistry, as an independent test or in combination with HPV testing in low\u2010risk screening populations, however, will require subsequent large\u2010scale prospective clinical trials. Cancer (Cancer Cytopathol) 2010. \u00a9 2010 American Cancer Society.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cncy.20078","type":"journal-article","created":{"date-parts":[[2010,5,5]],"date-time":"2010-05-05T17:00:53Z","timestamp":1273078853000},"page":"146-156","source":"Crossref","is-referenced-by-count":36,"title":["p16<sup>INK4a<\/sup> is superior to high\u2010risk human papillomavirus testing in cervical cytology for the prediction of underlying high\u2010grade dysplasia"],"prefix":"10.1002","volume":"118","author":[{"given":"Panduka","family":"Samarawardana","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donna 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