Immunocytochemical staining for p16, Ki-67, and MCM2 in the detection of cervical lesions and cancer: a prospective observational study

HR-HPV-based primary screening with p16/Ki-67 triage may offer a viable strategy for cervical cancer detection. Combining LBC with p16/MCM2 dual staining demonstrated improved sensitivity and specificity compared to conventional methods. Notably, p16/MCM2 as a standalone assay achieved the highest Youden index when using a high-risk threshold. Further validation through multicenter studies is essential to confirm its generalizability.