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Evaluation of p16 INK4a expression in ThinPrep cervical specimens with the CINtec p16 INK4a assay
Author(s) -
Meyer Jane L.,
Hanlon David W.,
Andersen Birthe T.,
Rasmussen Ole F.,
Bisgaard Kirsten
Publication year - 2007
Publication title -
cancer cytopathology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.22580
Subject(s) - medicine , cytology , cervical intraepithelial neoplasia , biopsy , papanicolaou stain , papanicolaou test , pathology , pap test , human papillomavirus , cytopathology , cervical cancer , cervical cancer screening , cancer
Abstract BACKGROUND. The aim of this study was to examine p16 INK4a protein expression in ThinPrep (Cytyc Corporation, Marlborough, Mass) cervical specimens by using the CINtec p16 INK4a Cytology Kit (Dako, Glostrup, Denmark). The ability of this assay to accurately identify underlying high‐grade lesions was assessed by using follow‐up biopsies and comparing these results with Hybrid Capture 2 (Digene, Gaithersburg, Md) high‐risk HPV (hc 2 ) results. METHODS. Three hundred ninety‐eight residual ThinPrep samples were collected, and histological follow‐up data were retrieved for abnormal cytology specimens. After preparation of a Papanicolaou‐stained slide, a second slide was processed in preparation for p16 INK4a immunostaining. High‐risk human papillomavirus testing (hc 2 ) was also performed. RESULTS. Of the 163 cytologically abnormal samples, 6‐month biopsy follow‐up data were available for 45% of the specimens. At initial blinded evaluation, 21 of the 26 cases with cervical intraepithelial neoplasia (CIN) II/III follow‐up were positive for p16 INK4a , yielding an overall diagnostic sensitivity of 81%; 29 of the 47 cases diagnosed as CIN I or less were p16 INK4a negative, yielding a diagnostic specificity of 62%. In comparison, the hc 2 test results indicated a diagnostic sensitivity of 100% with a diagnostic specificity of 15%. After review of selected cases with CIN II/III follow‐up, 25 of 26 slides were deemed to be positive for p16 INK4a , increasing the diagnostic sensitivity to 96%. CONCLUSIONS. The CINtec p16 INK4a Cytology Kit, in combination with ThinPrep cervical samples, allowed clear evaluation of p16 INK4a protein overexpression. Diagnostic specificity of the CINtec p16 INK4a assay was significantly improved relative to hc 2 . To increase p16 INK4a immunostaining in abnormal cells, a modified kit version with improved staining performance has been developed and is currently being evaluated. Cancer (Cancer Cytopathol) 2007. © 2007 American Cancer Society.