Evaluation of p16/Ki-67 dual staining in the detection of cervical precancer and cancer in China

•Co-expression of p16 and Ki-67 indicated transformation, supposed to be more specific.•p16/Ki-67 was similar to HR-HPV in sensitivity but specificity was higher.•p16/Ki-67 had a good clinical performance for triage of women with ASC-US.•p16/Ki-67 is promising for use in China’s national cervical cancer screening. Background This study aimed to evaluate the clinical performance of p16/Ki-67 dual staining in the detection of cervical intraepithelial neoplasia grade 2 or 3 or worse (CIN2+/CIN3+) in Chinese women. Methods Cervical exfoliated cells were collected from 537 eligible women and were used for liquid-based cytology (LBC), p16/Ki-67 dual staining, and human papillomavirus (HPV) DNA testing. All women received colposcopy with biopsies taken at abnormal sites. Histopathological diagnoses were used as the gold standard. Results p16/Ki-67 staining had a positivity rate of 43.58% overall; the rate increased significantly with histological severity (p 30 years. With respect to the performance of triage for women with ASC-US, sensitivities of p16/Ki-67 were 86.36% for detecting CIN2+ and 83.33% for detecting CIN3+, values similar to those of HR-HPV. However, specificities of p16/Ki-67 were both higher than those of HR-HPV (85.96% versus 67.54% for CIN2+, 79.84% versus 62.90% for CIN3+). Conclusion P16/Ki-67 dual staining could probably provide an optional method for China’s national cervical cancer screening, and could also be considered as an efficient method of triage for managing women with ASC-US.