To Evaluate the Role of p16Ink4a Immunocytochemistry for Detection of CIN2+ in Women Detected Screen Positive by Visual Inspection Using Acetic Acid.

Abstract

Objective:To evaluate the role of p16Ink4a immunostaining for the detection of cervical intraepithelial neoplasia (CIN2+) in women who had a positive screening test using visual inspection with acetic acid (VIA).Methods:Opportunistic screening of women (30–50 years) coming to the gynecology clinic by VIA was performed; the screen-positive women were included in the study which had the institutional review board (IRB) approval. A cytology slide for p16Ink4a immunostaining, colposcopy, and biopsy was then performed sequentially. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of p16Ink4a immunocytochemistry were evaluated with histopathology as the gold standard.Results:p16Ink4a positivity showed a linear correlation with the increasing grade of CIN. p16Ink4a positivity was seen in 6% of CIN 1, 80% of CIN 2, 100% of CIN 3, and squamous cell carcinoma. The sensitivity and specificity of p16Ink4a immunocytochemistry for detecting CIN 2 or more was 87.5% (95%CI 61.65–98.45) and 97.06% (95%CI 84.67–99.93). Colposcopy had an equal sensitivity of 87.5% (95% CI 61.65–98.45) and specificity of 50% (95% CI 32.43–67.57), respectively.Conclusion:With high sensitivity and specificity, p16Ink4a immunocytochemistry could be a viable option for triaging VIA-positive women.