Diagnostic utility of p16 and Ki-67 immunohistochemical markers in cervical intraepithelial neoplasia: Association with HPV status and histological grade

*1Ogunyemi, D. T., 1Sodiya, H. A., 2Somade, O., and 3Kawu, S.

1Department of Morbid Anatomy and Histopathology, Olabisi Onabanjo University Teaching Hospital,               Sagamu, Nigeria

2Department of Obstetrics and Gynaecology, State Hospital, Abeokuta, Nigeria

3Department of Pathology, Gombe State University, Gombe, Nigeria

*Correspondence to: ogunyemidamilare@gmail.com; +2348140093814

 

Abstract:

 Background: Cervical intraepithelial neoplasia (CIN) is a precursor to cervical cancer, often associated with high-risk human papillomavirus (HPV) infection. Accurate diagnosis and grading of CIN are critical for effective management. Immunohistochemical markers like p16 and Ki-67 can enhance diagnostic precision by identifying oncogenic HPV-induced changes and cellular proliferation. This study evaluates the diagnostic utility of p16 and Ki-67 expression in CIN lesions and association with HPV status and histological grade.

Methodology: This retrospective study analyzed archived cervical biopsy samples diagnosed with CIN over a 5-year period in a tertiary care center in Sagamu, Ogun State, Nigeria. Histological grading of CIN was confirmed, and immunohistochemical staining for p16 and Ki-67 was performed. HPV status was determined using polymerase chain reaction (PCR) on the biopsy sample. Marker expression patterns were compared across CIN grades and with HPV status. Statistical association of p16 and Ki-67 expression with CIN grades and HPV was done using Chi-square or Fisher Exact test, with p<0.05 considered as statistical significance.

Results: Of the 72 samples analyzed, p16 expression showed a significant association with higher CIN grades and HPV positivity (p<0.001), with sensitivity and specificity values of 92.0% and 88.0%, respectively. Ki-67 expression was also associated with increasing CIN grades and HPV status (p=0.001), and demonstrated a sensitivity of 85.0% and specificity of 82.0% in distinguishing CIN lesions.

Conclusion: p16 and Ki-67 immunohistochemical markers are valuable adjuncts in the diagnosis and grading of CIN, particularly when correlated with HPV status. Their combined use can enhance diagnostic accuracy, supporting their incorporation into routine pathology workflows for CIN evaluation.

 Keywords: Biomarkers, cervical biopsy, CIN, HPV, Ki67, p16

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Diagnostic utility of p16 and Ki-67 immunohistochemical markers in cervical intraepithelial neoplasia: Association with HPV status and histological grade