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Review
. 2025 Jun 15;156(12):2257-2264.
doi: 10.1002/ijc.35353. Epub 2025 Feb 4.

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

Diane M Harper  1 , Tamera Paczos  2 , Ruediger Ridder  3 , Warner K Huh  4
Affiliations
Review

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

Diane M Harper et al. Int J Cancer. .

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.

Keywords: HPV; cervical cancer screening; dual stain; triage.

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Conflict of interest statement

T. P. has been a speaker and consultant to Roche Diagnostics. R. R. is an employee of Roche Diagnostics and reports minority stock ownership in Roche Holding AG. The other authors have no conflicts to declare.

Figures

FIGURE 1
FIGURE 1
Dual stain of p16 (brown, in the cytoplasm) and Ki‐67 (red, in the nucleus) in the same cell.
FIGURE 2
FIGURE 2
Sensitivity of different triage methods for detection of CIN3+ at baseline or cumulative over 1 year in the IMPACT trial. CIN, cervical intraepithelial neoplasia.
FIGURE 3
FIGURE 3
1‐, 3‐, and 5‐year risk of CIN3+ by cervical cytology or dual stain results at baseline in a KPNC study. ASC‐US, atypical squamous cells of undetermined significance; CIN, cervical intraepithelial neoplasia; NILM, negative for intraepithelial lesion or malignancy.
FIGURE 4
FIGURE 4
1‐, 3‐, and 5‐year risk of CIN3+ by cervical cytology combined with dual stain results. ASC‐US, atypical squamous cells of undetermined significance; CIN, cervical intraepithelial neoplasia; NILM, negative for intraepithelial lesion or malignancy.
See this image and copyright information in PMC

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