HPV genotyping and p16÷Ki-67 dual staining in the detection of high-grade cervical lesion in patients with LSIL on Pap smear.

p16÷Ki-67 dual-stained cytology, either alone or combined with human papillomavirus (HPV) 16÷18 genotyping, could be a useful tool for triage for colposcopy of HPV-positive patients. Based on this background, we aimed at comparing the diagnostic performance of the p16÷Ki-67 dual staining test, and high-risk HPV test for the detection of high-risk cervical intraepithelial neoplasia (CIN2÷3) in patients diagnosed with low-grade squamous intraepithelial lesion (LSIL) on Pap smear. We performed a retrospective study including 184 patients with LSIL cytology on Pap smear, of which 64 were referred for biopsy after colposcopy. Prior biopsy HPV genotyping and dual staining test were performed on all 64 patients. The mean age of the patients selected for conization was 36 years and seven months. The pathological exam showed that 28.13% (18÷64) from the patients LSIL on cytology were actually having CIN2÷3: 12 cases with CIN2, five cases with CIN3 and one case of in situ cervical carcinoma. HPV positive were 56.25% (36÷64) of the patients with LSIL. The p16÷Ki-67 dual staining test was positive in 29.69% (19÷64) of the patients with LSIL. Among women with LSIL cytology, the sensitivity and specificity of the HPV genotyping test for predicting CIN2÷CIN3 were 94.44% (17÷18) and 58.7% (27÷46), respectively. The sensitivity and specificity of the p16÷Ki-67 dual staining test were 66.67% (12÷18) and 84.78% (39÷46), respectively. Our results agree with other data available in literature and suggest that the p16÷Ki-67 dual staining test could be included in the management protocol of patients with modified cytology as a triage test before referring those patients for colposcopy.