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Immunocytochemical colocalization of P16(INK4a) and Ki-67 predicts CIN2/3 and AIS/adenocarcinoma.

AbstractBACKGROUND:
Although previous studies have shown that p16(INK4a) and Ki-67 are sensitive and specific markers for high-grade lesions (≥CIN2) on cervical biopsies, limited information is available regarding the performance of a dual-staining approach as a diagnostic adjunct in cervical cytology. We evaluated a dual p16(INK4a)/Ki-67 immunocytochemistry (ICC) assay to determine its sensitivity and specificity versus that of high-risk HPV (HR-HPV) in a US-based pilot cytology study.
METHODS:
ThinPrep specimens from 122 cervical cytology specimens encompassing 23 negative (NILM), 20 ASC-US, 22 LSIL, 17 ASCH, 22 HSIL, and 18AGC cases were processed for multiplexed ICC staining using a CINtec Plus Kit. Dual-positive assay results were defined based on the detection of 1 or more epithelial cells that were stained for both p16INK4a and Ki-67 without regard to cellular morphology. HR-HPV testing was performed by multiplex PCR with capillary electrophoresis genotyping.
RESULTS:
Dual staining for p16(INK4a) and Ki-67 was frequently detected in HSIL and AGC but was rarely detected in NILM cases. The HR-HPV assay showed a sensitivity of 76.2% and a specificity of 55.8% for the detection of clinically significant cervical squamous or endometrial lesions. In contrast, the colocalization of p16(INK4a) plus Ki-67 maintained a high sensitivity of 81.8% and improved specificity to 81.8% for biopsy-confirmed CIN2/3, endocervical adenocarcinoma, or endometrial adenocarcinoma.
CONCLUSIONS:
Dual staining for p16(INK4a)/Ki-67 immunocytochemistry dramatically increased specificity and maintained high-level sensitivity for the diagnosis of CIN2/3 or glandular lesions compared with PCR-based testing for HR-HPV.
AuthorsMeenakshi Singh, Daniel Mockler, Ali Akalin, Stephanie Burke, A Laurie Shroyer, Kenneth R Shroyer
JournalCancer cytopathology (Cancer Cytopathol) Vol. 120 Issue 1 Pg. 26-34 (Feb 25 2012) ISSN: 1934-6638 [Electronic] United States
PMID22162342 (Publication Type: Evaluation Study, Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Cyclin-Dependent Kinase Inhibitor p16
  • Ki-67 Antigen
Topics
  • Adenocarcinoma (diagnosis)
  • Carcinoma, Squamous Cell (diagnosis)
  • Cyclin-Dependent Kinase Inhibitor p16 (analysis)
  • Cytodiagnosis
  • Early Detection of Cancer (methods)
  • Female
  • Humans
  • Immunohistochemistry (methods)
  • Ki-67 Antigen (analysis)
  • Multiplex Polymerase Chain Reaction
  • Papillomavirus Infections (diagnosis)
  • Pilot Projects
  • Sensitivity and Specificity
  • Uterine Cervical Neoplasms (diagnosis, virology)
  • Uterine Cervical Dysplasia (diagnosis)

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