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Using a dual immunocytochemical staining protocol, testing for the biomarker p16/Ki-67, which is indicative of transforming HPV infections, has a higher specificity for high-grade cervical lesions than conventional cytology and HPV genotyping. The STAIN-IT (Screening Triage Ascertaining Intraepithelial Neoplasia by Immunostain Testing) study compared the clinical performance of p16/Ki67 dual-staining and HPV genotyping, via different algorithms in women referred to colposcopy.