title: ELISA test to detect CDKN2A (p16(INK4a)) expression in exfoliative cells: a new screening tool for cervical cancer.
abstract: BACKGROUND
  The purpose of this study was to use an enzyme-linked immunosorbent assay (ELISA) to detect cyclin-dependent kinase inhibitor 2A (CDKN2A; also known as p16(INK4a)) in exfoliative cervical cells. CDKN2A is upregulated and considered as a surrogate marker for cervical intraepithelial neoplasia and cancer.
  
  
  METHODS
  Liquid-based ThinPrep((R)) cytologic test (TCT) and ELISA were performed on 1356 specimens collected prior to biopsy. A cotton swab was used to gather exfoliative cells. A sandwich ELISA was performed to measure the amount of solublized CDKN2A protein.
  
  
  RESULTS
  The sensitivity and specificity of the TCT for screening of cervical dysplasia and cancer were 82.93% and 88.11%, respectively. The sensitivity and specificity for measuring CDKN2A with ELISA to detect significant cervical disease were 87.80% and 92.43%, respectively. CDKN2A expression was correlated with the severity of cervical damage (r = 0.774; p < 0.001).
  
  
  CONCLUSIONS
  The sensitivity and specificity of detecting CDKN2A expression with ELISA in exfoliative cervical cells was superior to TCT (p = 0.023 and p < 0.001, respectively). These results suggest that detecting CDKN2A with ELISA has the potential to become a new screening method for cervical cancer.
authors.affiliation: Department of Pathology, Jingmen Hubei Province First Peoples' Hospital, Jingmen, China.
authors.forename: Li
authors.initials: L
authors.lastname: Ding
authors.forename: Xian-Jin
authors.initials: XJ
authors.lastname: Zou
authors.forename: Jin-E
authors.initials: JE
authors.lastname: Ao
authors.forename: Ai-Xiang
authors.initials: AX
authors.lastname: Yao
authors.forename: Lan
authors.initials: L
authors.lastname: Cai
mesh_terms: D000328:Adult; D000368:Aged; D002584:Cervix Uteri / Q000166:cytology*; D019941:Cyclin-Dependent Kinase Inhibitor p16 / Q000378:metabolism*; D055088:Early Detection of Cancer; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000473:pathology; D055815:Young Adult
chemical_list: D019941:Cyclin-Dependent Kinase Inhibitor p16