Harvard TH Chan School of Public Health, Boston, MA, USA; Department of Public Health, Kitasato University School of Medicine, Kanagawa, Japan.
Department of Pulmonology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
Clin Microbiol Infect. 2017 Dec;23(12):907-915. doi: 10.1016/j.cmi.2017.05.009. Epub 2017 May 12.
We aimed to assess diagnostic test accuracy of antigenaemia assay for PCR-proven cytomegalovirus (CMV) infection.
We systematically searched studies that provide data both on sensitivity and specificity of the CMV antigenaemia assay using the PCR as the reference standard. Adults, children, infants, individuals who were immunocompromised for any reason, symptomatic patients and asymptomatic individuals were all included. A hierarchical summary receiver operating characteristics model was used for diagnostic meta-analysis. Study quality was assessed by Revised Tool for the Quality Assessment of Diagnostic Accuracy Studies. Protocol registration identification is CRD42016035892.
We identified 75 eligible articles including 9058 CMV PCR-positive individuals and 22 232 PCR-negative individuals. The diagnostic odds ratio for positive antigenaemia was 30 (95% CI 24-38, I = 28%) and the area under the hierarchical summary receiver operating characteristic curve was 0.86 (95% CI 0.83-0.88). The summary estimates of sensitivity and specificity were 0.65 (95% CI 0.59-0.70) and 0.94 (95% CI 0.93-0.95), respectively. The positive likelihood ratio of 10.9 (95% CI 8.5-14.0) suggested that a positive result from the antigenaemia assay greatly increased the probability of PCR-proven CMV infection, but a negative likelihood ratio of 0.38 (95% CI 0.32-0.44) indicated that a negative result led to a small decrease in the probability of PCR-proven CMV infection. Sensitivity and subgroup analyses replicated these results.
The antigenaemia assay overlooked 35% of PCR-proven CMV infections; hence, a negative result of an antigenaemia assay could not rule out a CMV infection.
评估抗原血症检测对聚合酶链反应（PCR）确诊的巨细胞病毒（CMV）感染的诊断测试准确性。
我们系统地搜索了提供抗原血症检测的敏感性和特异性数据的研究，这些研究均以 PCR 作为参考标准。纳入对象包括成年人、儿童、婴儿、因任何原因免疫功能低下的个体、有症状的患者和无症状的个体。使用分层汇总受试者工作特征模型进行诊断荟萃分析。研究质量采用修订后的诊断准确性研究质量评估工具进行评估。方案注册标识为 CRD42016035892。
我们确定了 75 篇符合条件的文章，其中包括 9058 例 CMV PCR 阳性个体和 22232 例 PCR 阴性个体。阳性抗原血症的诊断优势比为 30（95%置信区间 24-38，I=28%），分层汇总受试者工作特征曲线下面积为 0.86（95%置信区间 0.83-0.88）。敏感性和特异性的汇总估计值分别为 0.65（95%置信区间 0.59-0.70）和 0.94（95%置信区间 0.93-0.95）。阳性似然比为 10.9（95%置信区间 8.5-14.0）表明，抗原血症检测的阳性结果大大增加了 PCR 确诊 CMV 感染的概率，但阴性似然比为 0.38（95%置信区间 0.32-0.44）表明，阴性结果导致 PCR 确诊 CMV 感染的概率略有下降。敏感性和亚组分析复制了这些结果。
抗原血症检测漏诊了 35%的 PCR 确诊 CMV 感染；因此，抗原血症检测的阴性结果不能排除 CMV 感染。
