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Recently, p16INK4a/Ki-67 dual immunostaining has been introduced as a new biomarker protocol for early detection of uterine cervical dysplasia and cancer in liquid-based cytology (LBC). We performed the p16INK4a/Ki-67 dual immunostaining using a CINtec® PLUS kit in a total of 109 LBC cases of cervicovaginal smear and compared its results with those from LBC, HPV hybrid capture II (HC II) test and histological diagnosis. Expression of p16INK4a and Ki-67 was significantly associated with cases of LSIL or higher in cytological diagnosis and cases of cervical intraepithelial neoplasia (CIN) 1 or higher in histological diagnosis (p<0.001 and p<0.001, respectively). Among forty-six cases of atypical squamous cells of undetermined significance (ASCUS) in LBC, p16INK4a and Ki-67 was expressed in 31 (67.4%), which were positively associated with cases of CIN I lesion or higher in histology. The sensitivity of p16INK4a/Ki-67 dual immunostaining for finding lesions of CIN 1 or higher was 89.0%, which was higher than LBC. The specificity was 73.5%, which was higher than that of the HC II test. Based on these results, the p16INK4a/Ki-67 dual immunostaining method can be a useful diagnostic marker for improving the sensitivity of LBC and the specificity of HC II test.

Evaluation of p16INK4a/Ki-67 Dual Immunostaining in Liquid-based Cytology for Diagnosis of Uterine Cervical Dysplasia and Cancer

Evaluation of p16^INK4a/Ki-67 Dual Immunostaining in Liquid-based Cytology for Diagnosis of Uterine Cervical Dysplasia and Cancer