ELISA test to detect CDKN2A (p16(INK4a)) expression in exfoliative cells: a new screening tool for cervical cancer.
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.
Ding
Li
L
Department of Pathology, Jingmen Hubei Province First Peoples' Hospital, Jingmen, China.
Zou
Xian-Jin
XJ
Ao
Jin-E
JE
Yao
Ai-Xiang
AX
Cai
Lan
L
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
D019941:Cyclin-Dependent Kinase Inhibitor p16