Immunohistochemical Staining of p16 for the Screening of Cervical Cancer

Immunohistochemical Staining of p16 for the Screening of Cervical Cancer

Cyclin kinase inhibitor P16INK4A has overexpression in cervical cancer, and hence becoming an alternative method for cervical cancer screening. This study is to investigate the clinical value of P16INK4A and high-risk human papillomavirus (hrHPV) detection of cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+). All eligible participants accept P16INK4A testing, with cytology and/or hrHPV assay. P16INK4A immunohistochemical staining is performed on the retained specimens of cytology. The primary endpoint is the diagnostic accuracy of P16INK4A compared with cytology and/or hrHPV status based on histology results. The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.

Inclusion Criteria:

• Aged 18 years or older
• Signed an approved informed consents
• With sufficient cytology sample for p16 testing
• With definite results of cytology and/or high-risk human papillomavirus and cervical histology

Exclusion Criteria:

• Not meeting all of the inclusion criteria