实时聚合酶链反应检测疑似艰难梭菌感染患者粪便样本中艰难梭菌的诊断准确性：一项荟萃分析。
Diagnostic accuracy of real-time polymerase chain reaction in detection of Clostridium difficile in the stool samples of patients with suspected Clostridium difficile Infection: a meta-analysis.
机构信息
Department of Neurological Surgery, Neurological Institute, Neurological Institute, Desk S60, 9500 Euclid Ave, Cleveland Clinic, Cleveland, OH. USA.
出版信息
Clin Infect Dis. 2011 Oct;53(7):e81-90. doi: 10.1093/cid/cir505.
BACKGROUND
Current detection methods for Clostridium difficile infection (CDI) can be time-consuming and have variable sensitivities. Real-time polymerase chain reaction (PCR) may allow earlier and more accurate diagnosis of CDI than other currently available diagnostic tests. A meta-analysis was performed to determine the diagnostic accuracy of real-time PCR.
METHODS
We searched MEDLINE (Pubmed/Ovid) and 4 other online electronic databases (1995-2010) to identify diagnostic accuracy studies that compared PCR with cell culture cytotoxicity neutralization assay (CCCNA) or anaerobic toxigenic culture (TC) of C. difficile. Screening for inclusion, data extraction, and quality assessment were carried out independently by 2 investigators and disagreements resolved. Data were combined by means of a random-effects model, and summary receiver operating characteristic curves and diagnostic odds ratios were calculated.
RESULTS
Nineteen studies (7392 samples) met our inclusion criteria. The overall mean sensitivity of PCR was 90% (95% confidence interval [CI]: 88%-91%), specificity 96% (CI: 96%-97%), positive likelihood ratio 26.89 (CI: 20.81-34.74), negative likelihood ratio 0.11 (CI: .08-.15), diagnostic odds ratio 278.23 (CI: 213.56-362.50), and area under the curve 0.98 (CI: .98-.99). Test accuracy depended on the prevalence of C. difficile but not on the reference test used. At C. difficile prevalence of <10%, 10%-20% and >20% the positive predictive value and the negative predictive value were 71%, 79%, 93% and 99%, 98% and 96%, respectively.
CONCLUSIONS
Real-time PCR has a high sensitivity and specificity to confirm CDI. Overall diagnostic accuracy is variable and depends on CDI prevalence.
背景
目前检测艰难梭菌感染（CDI）的方法可能需要花费时间，且敏感度各异。实时聚合酶链反应（PCR）可能比其他现有的诊断检测方法更早、更准确地诊断 CDI。我们进行了一项荟萃分析以确定实时 PCR 的诊断准确性。
方法
我们检索了 MEDLINE（Pubmed/Ovid）和其他 4 个在线电子数据库（1995-2010 年），以确定比较 PCR 与细胞培养细胞毒性中和试验（CCCNA）或艰难梭菌厌氧产毒培养（TC）的诊断准确性研究。通过两位研究者独立进行纳入筛选、数据提取和质量评估，并解决分歧。通过随机效应模型合并数据，并计算汇总受试者工作特征曲线和诊断比值比。
结果
19 项研究（7392 个样本）符合纳入标准。PCR 的总体平均敏感度为 90%（95%置信区间 [CI]：88%-91%），特异性为 96%（CI：96%-97%），阳性似然比为 26.89（CI：20.81-34.74），阴性似然比为 0.11（CI：0.08-0.15），诊断比值比为 278.23（CI：213.56-362.50），曲线下面积为 0.98（CI：0.98-0.99）。检测准确性取决于艰难梭菌的流行程度，但与参考检测方法无关。在艰难梭菌流行率<10%、10%-20%和>20%时，阳性预测值和阴性预测值分别为 71%、79%、93%和 99%、98%和 96%。
结论
实时 PCR 具有较高的敏感度和特异性，可用于确诊 CDI。总体诊断准确性因 CDI 流行率而异。
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