Evaluation of CINtec PLUS® testing as an adjunctive test in ASC-US diagnosed SurePath® preparations
Version of Record online: 27 JUN 2011
Copyright © 2011 Wiley Periodicals, Inc.
Volume 41, Issue 1, pages 35–40, January 2013
How to Cite
Edgerton, N., Cohen, C. and Siddiqui, M. T. (2013), Evaluation of CINtec PLUS® testing as an adjunctive test in ASC-US diagnosed SurePath® preparations. Diagn. Cytopathol., 41: 35–40. doi: 10.1002/dc.21757
- Issue online: 17 DEC 2012
- Version of Record online: 27 JUN 2011
- Manuscript Accepted: 11 MAY 2011
- Manuscript Received: 21 MAR 2011
- Ki-67, MIB1;
The CINtec PLUS® system is an immunohistochemical cocktail composed of antibodies against p16INK4a (surrogate of HPV infection) and Ki-67 (proliferation marker) meant to improve the sensitivity and specificity for detecting high-grade dysplasia (HGD). In the presence of dysplasia, a red chromogen marks Ki-67 expression in the nucleus and a brown chromogen marks cytoplasmic p16INK4a expression. Only cells showing dual staining are interpreted as positive. This retrospective study examined the performance of CINtec PLUS testing when performed on ASC-US diagnosed samples. Comparison was made to high-risk HPV DNA test results and colposcopic biopsy results. Technical considerations in the interpretation of this immunohistochemical stain are additionally discussed. CINtec PLUS showed modest sensitivity (64%) and specificity (53%) in identifying the presence of HGD at surgical biopsy. Positive and negative predictive values for HGD were 28% and 83%, respectively. HR-HPV DNA test yielded sensitivity of 100% and specificity of 21%. During interpretation, squamous metaplasia and endocervical cells were seen to show individual staining for p16INK4a or Ki-67. Individual staining, when present within three dimensional cellular groups common to SurePath® preparations, can be time-intensive to interpret necessitating thoughtful examination at high power. The Pap test with HR-HPV DNA testing is a highly sensitive test. A specific test is needed to prevent false positives and over treatment. The CINtec® system provides a modest increase in specificity beyond HR-HPV DNA testing. Future study of its appropriateness and cost-ffectiveness in a treatment algorithm are warranted. Diagn. Cytopathol. 2013. © 2011 Wiley Periodicals, Inc.