Data_Sheet_1_Feasibility of Immunohistochemical p16 Staining in the Diagnosis of Human Papillomavirus Infection in Patients With Squamous Cell Carcinoma of the Head and Neck: A Systematic Review and Meta-Analysis.zip

Human papillomavirus (HPV) is a risk factor for squamous cell carcinoma of the head and neck (HNSCC). This study aimed to investigate the feasibility of IHC- p16INK4a (p16) as an alternative modality for diagnosing HPV infection. We searched PubMed, EMBASE, Web of Science, and Cochrane library for studies that evaluated the diagnostic accuracy of IHC-p16 staining. A total of 30 studies involving 2,963 patients were included from 2007 to 2019. The combined sensitivity was 0.94 (95% CI: 0.92–0.95); specificity, 0.90 (95% CI: 0.89–0.91); positive likelihood ratio (LR), 6.80 (95% CI: 5.63–8.21); negative LR, 0.10 (95% CI: 0.07–0.16); diagnostic odds ratio, 85.98 (95% CI: 55.57–133.03); and area under the curve value, 0.9550. Subgroup analysis showed that the IHC-p16 test was more consistent with the in situ hybridization (ISH) test and has greater diagnostic value for oropharyngeal squamous cell carcinoma. The diagnostic efficacy of IHC-p16 varied among countries. In conclusion, IHC-p16 has high sensitivity and specificity for diagnosing HPV infection in HNSCC. The consistency of IHC-p16 findings with those of ISH indicate that their combination can be used to improve the specificity of diagnosis.

人类乳头瘤病毒（Human papillomavirus, HPV）是头颈部鳞状细胞癌（squamous cell carcinoma of the head and neck, HNSCC）的危险因素。本研究旨在探讨免疫组化p16INK4a（IHC-p16INK4a，简称p16）作为HPV感染诊断替代检测手段的可行性。研究团队检索了PubMed、EMBASE、Web of Science及科克伦图书馆（Cochrane Library）中评估IHC-p16染色诊断准确性的相关研究。最终纳入2007年至2019年间的30项研究，共涉及2963例患者。合并分析结果如下：合并灵敏度为0.94（95%置信区间：0.92~0.95）；合并特异度为0.90（95%置信区间：0.89~0.91）；阳性似然比（LR）为6.80（95%置信区间：5.63~8.21）；阴性似然比为0.10（95%置信区间：0.07~0.16）；诊断比值比为85.98（95%置信区间：55.57~133.03）；曲线下面积值为0.9550。亚组分析显示，IHC-p16检测与原位杂交（in situ hybridization, ISH）结果一致性更佳，且对口咽鳞状细胞癌的诊断价值更高。不同国家间IHC-p16的诊断效能存在差异。综上，IHC-p16在HNSCC相关HPV感染的诊断中具备较高的灵敏度与特异度；其检测结果与ISH结果具有良好一致性，二者联合应用可有效提升诊断特异度。