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ELISA Test to Detect CDKN2A (p16INK4a) 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 p16INK4a) in exfoliative cervical cells. CDKN2A is upregulated and considered as a surrogate marker for cervical intraepithelial neoplasia and cancer.

Methods: Liquid-based ThinPrep® 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).

Conclusion: 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.

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The authors wish to thank Boster Biotechnology Limited Company (Wu-Han, China) for their technical assistance and the supply of products used in this study, and the Department of Gynecology at Jingmen Hubei Province First Peoples’ Hospital for sample collection. Special thanks go to all the patients who participated in this trial.

The authors have no conflicts of interest that are directly relevant to the content of this study.

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Correspondence to Dr Xian-jin Zou.

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Ding, L., Zou, X., Ao, J. et al. ELISA Test to Detect CDKN2A (p16INK4a) Expression in Exfoliative Cells. Mol Diag Ther 12, 395–400 (2008).

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  • Cervical Cancer
  • Cervical Intraepithelial Neoplasia
  • Cervicitis
  • Atypical Squamous Cell
  • Mean Optical Density