{"doi":"10.1101/2025.01.26.25321149","title":"Evaluation of p16/Ki- 67 cytology as triage test for high-risk HPV-positive women in a “see and treat strategy”","abstract":"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.","journal":"medRxiv","year":2025,"id":561088,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":0,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9546,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2025-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1334529,"name":"Lilian Ogonda","orcid":null,"position":1,"is_corresponding":false},{"id":342435,"name":"Bernard Guyah","orcid":"0000-0002-9936-9996","position":2,"is_corresponding":false},{"id":1334048,"name":"Calleb George Onyango","orcid":"0000-0001-5743-6057","position":0,"is_corresponding":true}],"reference_count":26,"raw_metadata":null,"created_at":"2026-07-19T02:55:46.921885Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}