The value of p16INK4a immunostaining for high-grade squamous intraepithelial lesions in human papillomavirus-negative patients

Abstract Background This study aims to evaluate the value of p16INK4a immunostaining for high-grade squamous intraepithelial lesions in human papillomavirus-negative patients in Beijing, China. Methods In this study, we evaluated the value of p16INK4a immunostaining, as well as cytology and colposcopy, for predicting high-grade squamous intraepithelial lesions (HSIL) in human papillomavirus (HPV)-negative patients by comparing the methods with the haematoxylin and eosin (H&E) staining pathological diagnosis of HPV-negative patients. Results Of 122 patients negative for the high-risk HPV (hrHPV) subtype, 26 (21.3%) underwent colposcopically directed multiple punch cervical biopsies with H&E pathological diagnoses of HSIL and above (HSIL+), 11 patients (9.0%) had cervical intraepithelial neoplasia (CIN)2, nine patients (7.4%) had CIN3 and six patients (4.9%) had infiltrating carcinomas. Cytology, colposcopy and p16INK4a immunostaining had 52.4%, 38.5% and 92.3% sensitivity, respectively, and 76.2%, 94.8% and 99% specificity, respectively. The positive predictive value of the cytology, colposcopy and p16INK4a immunostaining was 31.4%, 66.7% and 96%, respectively, and the negative predictive value was 88.5%, 85.1% and 97.9%, respectively. Compared with H&E staining, the kappa of the cytology, colposcopy and p16INK4a immunostaining was 0.327, 0.323 and 0.926, respectively. Conclusion Positive p16INK4a immunostaining is very strongly consistent with an H&E diagnosis of CIN2+, and it can be used as an objective detection index for HSIL+ diagnoses of HPV-negative patients with CIN2+.