Diagnostic value of cell block technique combined with p16/Ki-67 double staining in cervical cancer screening ≥CIN2 with cytological results of ASC-US/LSIL

Background: Accurate screening for ≥ CIN2 in patients with cytologic results of ASC-US/LSIL is key to cervical cancer screening, which will benefit women by reducing the psychosocial impact of having repeated abnormal smears and undergoing colposcopy. Methods To analyze the potential role of the p16/Ki-67 double-stained(DS) on cell block (CB) assay on cytological results of atypical squamous cells of undetermined significance(ASC-US) and low-grade squamous intraepithelial lesion (LSIL) in a final pathological diagnosis of ≥ cervical intraepithelial neoplasia (CIN)2 lesion. We screened ASC-US/LSIL cases with complete results of high-risk human papillomavirus (HR-HPV) and DNA ploidy analysis, and based on the principle of informed consent and voluntariness, the patients' remaining Liquid Based Cytology(LBC) specimens were subjected to CB. A total of 222 patients underwent colposcopic biopsy to compare and analyze the diagnostic efficacy of the three screening methods for ≥ CIN2. Results The Area Under the Curve (AUC) of p16/Ki-67 DS was significantly higher than that of HR-HPV and DNA ploidy, P < 0.01. Net reclassification improvement (NRI) index results showed that compared with HR-HPV and DNA ploidy, p16/Ki-67 DS on CB increased the percentage of patients correctly classified by 147.0% and 127.8%, respectively, P < 0.01. The results of the integrated discrimination improvement index (IDI) index showed that p16/Ki-67 increased diagnostic ability by 60.9% and 63.3%, P < 0.01. Conclusion The p16/Ki-67 DS on CB significantly improved the correct classification of patients with ≥ CIN2, was a good method to triage ASC-US/LSIL patients, and effectively avoided the occurrence of overdiagnosis and treatment.