16S Ribosomal Ribonucleic Acid Gene Polymerase Chain Reaction in the Diagnosis of Bloodstream Infections: A Systematic Review and Meta-Analysis

ObjectiveWe aim to evaluate the accuracy of the 16S ribosomal ribonucleic acid (rRNA) gene polymerase chain reaction (PCR) test in the diagnosis of bloodstream infections through a systematic review and meta-analysis.MethodsA computerized literature search was conducted to identify studies that assessed the diagnostic value of 16S rRNA gene PCR test for bloodstream infections. Study quality was assessed using the revised Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. We calculated the sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic odds ratio (DOR) and their 95% confidence intervals (95% CI) for each study. Summary receiver operating characteristic (SROC) curve was used to summarize overall test performance. Statistical analysis was performed in Meta-DiSc 1.4 and Stata/SE 12.0 software.ResultsTwenty-eight studies were included in our meta-analysis. Using random-effect model analysis, the pooled sensitivity, specificity, PLR, NLR, and DOR were 0.87 (95% CI, 0.85–0.89), 0.94 (95% CI, 0.93–0.95), 12.65 (95% CI, 8.04–19.90), 0.14 (95% CI, 0.08–0.24), and 116.76 (95% CI, 52.02–262.05), respectively. The SROC curve indicated that the area under the curve (AUC) was 0.9690 and the maximum joint sensitivity and specificity (Q*) was 0.9183. In addition, heterogeneity was statistically significant but was not caused by the threshold effect.ConclusionExisting data suggest that 16S rRNA gene PCR test is a practical tool for the rapid screening of sepsis. Further prospective studies are needed to assess the diagnostic value of PCR amplification and DNA microarray hybridization of 16S rRNA gene in the future.

研究目的
本研究旨在通过系统评价与meta分析，评估16S核糖体核糖核酸（rRNA）基因聚合酶链式反应（PCR）检测在血流感染诊断中的准确性。

研究方法
本研究通过计算机文献检索，筛选评估16S rRNA基因PCR检测对血流感染诊断价值的相关研究。采用修订版诊断准确性研究质量评价量表（QUADAS-2）对纳入研究的质量进行评价。分别计算各研究的灵敏度、特异度、阳性似然比（PLR）、阴性似然比（NLR）、诊断比值比（DOR）及其95%置信区间（95% CI）。采用综合受试者工作特征（SROC）曲线汇总该检测方法的整体诊断性能。统计分析采用Meta-DiSc 1.4及Stata/SE 12.0软件完成。

研究结果
本meta分析共纳入28项研究。采用随机效应模型分析后，合并灵敏度为0.87（95% CI：0.85~0.89），合并特异度为0.94（95% CI：0.93~0.95），合并阳性似然比为12.65（95% CI：8.04~19.90），合并阴性似然比为0.14（95% CI：0.08~0.24），合并诊断比值比为116.76（95% CI：52.02~262.05）。综合受试者工作特征曲线显示，曲线下面积（AUC）为0.9690，最大联合灵敏度与特异度（Q*）为0.9183。此外，研究间存在统计学显著性异质性，但该异质性并非由阈值效应所致。

研究结论
现有数据表明，16S rRNA基因PCR检测是用于脓毒症快速筛查的实用工具。未来仍需开展前瞻性研究，进一步评估16S rRNA基因PCR扩增与DNA微阵列杂交技术的诊断价值。