Use of p16/Ki67 Dual Stain for Management of Individuals Testing Positive for Human Papillomavirus

Publication Date: March 6, 2024

Last Updated: March 8, 2024

Summary of Recommendations

These recommendations only apply to FDA-approved DS cytology assays. Currently, CINtec PLUS Cytology (Roche Diagnostics) is the only DS test with FDA approval. The performance of other, non–FDA-approved p16/Ki67 assays may not be similar, and the generalizability of these recommendations cannot be assumed.
These recommendations apply only to results obtained in asymptomatic women; symptomatic women should undergo testing according to relevant protocols.
Because of limited data availability for multiple rounds of testing or for specific clinical scenarios, estimates for downstream risks of CIN3+ are either not available or are insufficient to allow for the development of risk-based recommendations for all possible scenarios related to DS testing. For example, this includes a scenario of postcolposcopy management when the squamocolumnar junction was not fully visualized and no histologic CIN2+ was found on colposcopic biopsy/endocervical curettage. In these situations where recommendations are not available, clinical judgment and shared decision-making should consider the 2019 Guidelines1 and 2017 Colposcopy Standards, where applicable, and may also consider the increased risk that follows from DS-positive test results and the decreased risk that follows from DS-negative test results. Additional recommendations may be generated as more data become available allowing robust risk estimation.