• Cheng-Chieh Chen, Lee-Wen Huang, Chyi-Huey Bai, and Chin-Cheng Lee.
• Dr. Chin-Cheng Lee, Department of Pathology and Laboratory Medicine,, Shin Kong Wu Ho-Su Memorial Hospital,, No. 95, Wen Change Road, Shih Lin District,, Taipei City, Taipei, 111 Taiwan, T: 886-2-28332211 ext. 2121,, F: 886-2-28389360, M002058@ms.skh.org.tw, ORCID: http://orcid.org/0000-0002-3064-5016.
• Ann Saudi Med. 2016 Jul 1; 36 (4): 245251245-51.

BackgroundThe Papanicolaou (Pap) test is one screening strategy used to prevent cervical cancer in developed countries. The p16/Ki-67 immunocytochemistry is a triage test performed on Pap smears in women with atypical squamous cells of undetermined significance (ASCUS) or low grade squamous intraepithelial lesion.ObjectiveOur objective was to review studies investigating the diagnostic performance of p16/Ki-67 dual stain for triage of women with abnormal Pap tests.DesignWe conducted a systematic review and meta-analysis of diagnostic test accuracy studies.SettingsWe followed the protocol of systematic review of diagnostic accuracy studies.Patients And MethodsWe searched PubMed, The Cochrane Library, BioMed Central, and ClinicalTrials.gov for relevant studies. We included research that assessed the accuracy of p16/Ki-67 dual stain and high risk human papillomavirus testing for triage of abnormal Pap smears. Review articles and studies that provided insufficient data to construct 2.2 tables were excluded. Data synthesis was conducted using a random-effects model.Main Outcome MeasuresSensitivity and specificity.ResultsIn seven studies encompassing 2628 patients, the pooled sensitivity and specificity of p16/Ki-67 for triage of abnormal Pap smear results were 0.91 (95% CI, 0.89 to 0.93) and 0.64 (95% CI, 0.62 to 0.66), respectively. No study used a case-control design. A subgroup analysis involving liquid-based cytology showed a sensitivity of 0.91 (95%CI, 0.89 to 0.93) and specificity of 0.64 (95%CI, 0.61 to 0.66).ConclusionsOur meta-analysis of p16/Ki-67 dual stain studies showed that the test achieved high sensitivity and moderate specificity for p16/Ki-67 immunocytochemistry for high-grade squamous intraepi.thelial lesion and cervical cancer. We suggest that p16/Ki-67 dual stain might be a reliable ancillary method identifying high-grade squamous intraepithelial lesions in women with abnormal Pap tests.LimitationsNo study in the meta-analysis examined the accuracy of the p16/Ki-67 dual stain for inter.pretation of glandular neoplasms.

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