Evaluation of p16/Ki- 67 cytology as triage test for high-risk HPV-positive women in a “see and treat strategy”

Abstract Background Although high risk human papilloma virus DNA (hr-HPV-DNA) test is the primary tool for cervical cancer screening, with visual inspection with acetic acid (VIA) serving as a triage test where Pap cytology is not available, the low intra-observer agreement associated with VIA means its reliability is limited and a more efficient test is still required. The aim of this study was to compare the performance of p16/Ki-67 cytology with VIA in the detection of cervical precancer and the feasibility as an alternative triage in the “ see and treat strategy” . Methods In a hospital-based cross-sectional study, we utilized stored provider-collected specimens from a previous study of women referred with cervical abnormalities to a tertiary hospital in Kisumu County, Kenya from February 2021 to November 2023. Specimens were tested with both Xpert and p16/ki-67 Immunostain. All hr-HPV positive women with cervical lesions were triaged using VIA and p16/Ki- 67 cytology. CIN2 or worse (≥CIN2) were defined as the clinical end points. Results The p16/ Ki- 67 Immunostaining showed a statistically significant higher sensitivity (84.6% vs. 59.0%%), specificity (44.0% vs. 62.0%), positive predictive value (28.2% vs. 28.8%) and negative predictive value (91.7% vs. 85.3%) compared to VIA examination. Conclusion The p16/Ki-67 immunostaining for the detection of ≥CIN2 has shown high sensitivity and high negative predictive value in our study, which is comparable to several previous findings; implying that the assay is superior to VIA in identifying ≥CIN2 and can serve as an alternative tool for triaging primary HPV-positive women in the current “see and treat” strategy.