Application of P16/Ki-67 dual-staining for the detection of high-grade cervical lesions in the triage of patients with minor abnormal cytology: A meta-analysis
BackgroundThe p16/Ki-67 dual-staining is increasingly applied to increase diagnostic accuracy in detecting high-grade cervical lesions, including cervical intraepithelial neoplasia Grade 2 (CIN2+) and CIN3+.ObjectivesTo compare the diagnostic performance of p16/Ki-67 dual-staining with the human papillomavirus (HPV) tests in the triage of women with atypical squamous cells of undetermined significance (ASC-US) and low-grade squamous intraepithelial lesions (LSIL) cytology results.Search StrategyPublications before April 27, 2024, were identified through PubMed, Embase, Web of Science, and Cochrane Library.Selection CriteriaThe studies have head-to-head comparison of p16/Ki-67 dual-staining and HPV testing in detecting high-grade cervical lesions.Data Collection and AnalysisTwo researchers independently screened articles by title, abstract, and full text. The GRADE and QUADAS-2 tool was used for quality evaluation. The pooled sensitivity and specificity for CIN2+ and CIN3+ were estimated using random effects models, with results and heterogeneity assessments presented in forest plots. Pretest-posttest probability (PPP) plots were constructed to evaluate the detection rates of CIN3+ in ASC-US and LSIL patients.Main ResultsTwenty-one studies with 6394 participants were included. The pooled specificity of p16/Ki-67 dual-staining was higher than that of HPV tests (CIN2+: 0.73 [95% confidence interval [CI] 0.65-0.80] versus 0.41 [95% CI 0.33-0.50]; CIN3+: 0.61 [95% CI 0.53-0.69] versus 0.33 [95% CI 0.23-0.45]). Summary receiver operating characteristic curve analysis demonstrated p16/Ki-67 dual-staining had better diagnostic accuracy for CIN2+ than HPV tests (area under the curve: 0.88 [95% CI 0.85-0.90] versus 0.79 [95% CI 0.75-0.82]). Pretest-posttest probability (PPP) plots highlighted the superior performance of p16/Ki-67 dual-staining for colposcopy referrals in LSIL patients.ConclusionsP16/Ki-67 dual-staining offers greater specificity for detecting CIN2+/CIN3+ in ASC-US and LSIL triage, particularly for LSIL. It holds potential as an alternative to HPV tests in resource-limited settings or LSIL cases, warranting further research to refine its application in diverse populations.
基金：
Shanghai Professional Technology Service
Platform on Cold Chain Equipment
Performance and Energy Saving
Evaluation
第一作者机构：[1]Xiamen Univ, Sch Publ Hlth, Natl Inst Diagnost & Vaccine Dev Infect Dis, State Key Lab Mol Vaccinol & Mol Diagnost, Xiamen, Fujian, Peoples R China[2]Chinese Acad Med Sci & Peking Union Med Coll, Dept Canc Epidemiol, Natl Canc Ctr, Natl Clin Res Ctr Canc,Canc Hosp, 17 South,Panjiayuan Lane, Beijing 100021, Peoples R China
通讯作者：
推荐引用方式(GB/T 7714)：
Zhang Hua,Dai Yu,Zhou Hang,et al.Application of P16/Ki-67 dual-staining for the detection of high-grade cervical lesions in the triage of patients with minor abnormal cytology: A meta-analysis[J].INTERNATIONAL JOURNAL OF GYNECOLOGY & OBSTETRICS.2025,doi:10.1002/ijgo.70432.
APA：
Zhang, Hua,Dai, Yu,Zhou, Hang,Yang, Yuan,Pi, Ruoji...&Chen, Wen.(2025).Application of P16/Ki-67 dual-staining for the detection of high-grade cervical lesions in the triage of patients with minor abnormal cytology: A meta-analysis.INTERNATIONAL JOURNAL OF GYNECOLOGY & OBSTETRICS,,
MLA：
Zhang, Hua,et al."Application of P16/Ki-67 dual-staining for the detection of high-grade cervical lesions in the triage of patients with minor abnormal cytology: A meta-analysis".INTERNATIONAL JOURNAL OF GYNECOLOGY & OBSTETRICS .(2025)
