p16/ki-67 dual stain triage of individuals positive for HPV to detect cervical precancerous lesions.

Abstract

p16/Ki-67 dual stain is a biomarker-based test that can identify oncogenic transformation in cervical cells with higher sensitivity than cervical cytology, using the same samples taken for human papillomavirus (HPV) testing and liquid-based cytology. Dual stain is approved by the US Food and Drug Administration (FDA) for triage of women with positive results by primary HPV testing or by HPV/cytology co-testing and has recently been incorporated into management guidelines. In this review, we summarize the data showing the utility of dual stain in detecting precancers, reducing the number of unnecessary colposcopies, and reassuring women who test negative. We also discuss the implications of dual stain for future treatment practice and health economics.