Department of Clinical Laboratory, Shandong Provincial Hospital Affiliated to Shandong First Medical University, 324 Jingwu Road, Jinan, People's Republic of China.
Braz J Microbiol. 2021 Dec;52(4):1937-1949. doi: 10.1007/s42770-021-00563-7. Epub 2021 Aug 29.
Accurate and rapid diagnosis of Clostridium difficile infection (CDI) is critical for effective patient management and implementation of infection control measures to prevent transmission.
We updated our previous meta-analysis to provide a more reliable evidence base for the clinical diagnosis of Xpert C. difficile (Xpert C. difficile) assay.
We searched PubMed, EMBASE, Cochrane Library, Chinese National Knowledge Infrastructure (CNKI), and the Chinese Biomedical Literature Database (CBM) databases to identify studies according to predetermined criteria. STATA 13.0 software was used to analyze the tests for sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, diagnostic odds ratio, and area under the summary receiver operating characteristic curves (AUC). QUADAS-2 was used to assess the quality of included studies with RevMan 5.2. Heterogeneity in accuracy measures was tested with Spearman correlation coefficient and chi-square. Meta-regressions and subgroup analyses were performed to figure out the potential sources of heterogeneity. Model diagnostics were used to evaluate the veracity of the data.
A total of 26 studies were included in the meta-analysis. The pooled sensitivity (95% confidence intervals [CI]) for diagnosis was 0.97(0.95-0.98), and specificity was 0.96(0.95-0.97). The AUC was 0.99 (0.98-1.00). Model diagnostics confirmed the robustness of our meta-analysis's results. Significant heterogeneity was still observed when we pooled most of the accuracy measures of selected studies. Meta-regression and subgroup analyses showed that the sample size and type, ethnicity, and disease prevalence might be the conspicuous sources of heterogeneity.
The up-to-date meta-analysis showed the Xpert CD assay had good accuracy for detecting CDI. However, the diagnosis of CDI must combine clinical presentation with diagnostic testing to better answer the question of whether the patient actually has CDI in the future, and inclusion of preanalytical parameters and clinical outcomes in study design would provide a more objective evidence base.
准确、快速诊断艰难梭菌感染（CDI）对于有效管理患者和实施感染控制措施以防止传播至关重要。
我们更新了之前的荟萃分析，为 Xpert C. difficile（Xpert C. difficile）检测的临床诊断提供更可靠的证据基础。
我们根据预设标准检索了 PubMed、EMBASE、Cochrane 图书馆、中国国家知识基础设施（CNKI）和中国生物医学文献数据库（CBM）数据库，以确定研究。使用 STATA 13.0 软件分析灵敏度、特异性、阳性似然比、阴性似然比、诊断比值比和汇总受试者工作特征曲线下面积（AUC）。使用 QUADAS-2 评估纳入研究的质量，使用 RevMan 5.2 进行 Meta 回归和亚组分析以确定异质性的潜在来源。使用模型诊断评估数据的真实性。
共纳入 26 项研究进行荟萃分析。诊断的汇总敏感性（95%置信区间[CI]）为 0.97（0.95-0.98），特异性为 0.96（0.95-0.97）。AUC 为 0.99（0.98-1.00）。模型诊断证实了我们荟萃分析结果的稳健性。当我们汇总大多数选定研究的准确性测量值时，仍观察到显著的异质性。Meta 回归和亚组分析表明，样本量和类型、种族和疾病流行率可能是异质性的显著来源。
最新的荟萃分析表明，Xpert CD 检测对 CDI 的检测具有良好的准确性。然而，CDI 的诊断必须将临床表现与诊断检测相结合，以更好地回答患者是否实际上患有 CDI 的问题，并且在研究设计中包含分析前参数和临床结果将提供更客观的证据基础。
