p16/ki‐67 dual‐stain cytology in the triage of ASCUS and LSIL Papanicolaou cytology
Top Cited Papers
- 25 March 2011
- journal article
- research article
- Published by Wiley in Cancer Cytopathology
- Vol. 119 (3), 158-166
- https://doi.org/10.1002/cncy.20140
Abstract
BACKGROUND: The objective of this study was to analyze the diagnostic performance of a newly established immunocytochemical dual‐stain protocol, which simultaneously detects p16INK4a and Ki‐67 expression in cervical cytology samples, for identifying high‐grade cervical intraepithelial neoplasia (CIN2+) in women with Papanicolaou (Pap) cytology results categorized as atypical squamous cells of undetermined significance (ASCUS) or low‐grade squamous intraepithelial lesions (LSIL). METHODS: Residual liquid‐based cytology material from 776 retrospectively collected ASCUS/LSIL cases that were available from a recent study evaluating p16 cytology and HPV testing were subjected to p16/Ki‐67 dual staining. The presence of 1 or more double‐immunoreactive cell(s) was regarded as a positive test outcome, irrespective of morphology. Test results were correlated to histology follow‐up. RESULTS: Sensitivity of p16/Ki‐67 dual‐stain cytology for biopsy‐confirmed CIN2+ was 92.2% (ASCUS) and 94.2% (LSIL), while specificity rates were 80.6% (ASCUS) and 68.0% (LSIL), respectively. Similar sensitivity/specificity profiles were found for both age groups of women aged <30 years versus women aged ≥30 years. Dual‐stain cytology showed comparable sensitivity, but significantly higher specificity, when compared with human papillomavirus (HPV) testing. CONCLUSIONS: The results of this study show that p16/Ki‐67 dual‐stain cytology provided a high sensitivity for the detection of underlying CIN2+ in women with ASCUS or LSIL Pap cytology results, comparable to the rates previously reported for HPV testing and p16 single‐stain cytology. However, the specificity of this morphology‐independent interpretation of p16/Ki‐67 dual‐stain cytology testing was further improved compared with the earlier p16 single‐stain cytology approach, which required morphology interpretation, and it is significantly higher when compared with HPV testing. Cancer (Cancer Cytopathol) 2011;. © 2011 American Cancer Society.Keywords
This publication has 22 references indexed in Scilit:
- The Sensitivity and Specificity of p16INK4a Cytology vs HPV Testing for Detecting High-Grade Cervical Disease in the Triage of ASC-US and LSIL Pap Cytology ResultsAmerican Journal of Clinical Pathology, 2010
- p16(INK4a) immunostaining in cytological and histological specimens from the uterine cervix: A systematic review and meta-analysisCancer Treatment Reviews, 2009
- Human Papillomavirus mRNA and p16 Detection as Biomarkers for the Improved Diagnosis of Cervical NeoplasiaCancer Epidemiology, Biomarkers & Prevention, 2008
- Are adjunctive markers useful in routine cervical cancer screening? Application of p16INK4a and HPV‐PCR on ThinPrep samples with histological follow‐upDiagnostic Cytopathology, 2008
- Evaluation of p16INK4a expression in ThinPrep cervical specimens with the CINtec p16INK4a assayCancer, 2007
- A comparison of the clinical utility of p16INK4a immunolocalization with the presence of human papillomavirus by hybrid capture 2 for the detection of cervical dysplasia/neoplasiaCancer, 2006
- Human Papillomavirus Triage for Young Women With Atypical Squamous Cells of Undetermined SignificanceObstetrics & Gynecology, 2006
- Immunocytochemistry in liquid-based cervical cytology: Analysis of clinical use following a cross-sectional studyInternational Journal of Cancer, 2005
- MIB-1 and PCNA immunostaining as a diagnostic adjunct to cervical Pap smearDiagnostic Cytopathology, 2005
- Immunocytochemical Expression of p16INK4A and Ki-67 in Cytologically Negative and Equivocal Pap Smears Positive for Oncogenic Human PapillomavirusInternational Journal of Gynecological Pathology, 2005