Department of Laboratory Medicine, Ewha Womans University College of Medicine, Seoul, Korea.
Department of Laboratory Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Ann Lab Med. 2021 Mar 1;41(2):171-180. doi: 10.3343/alm.2021.41.2.171.
Various methods are used for the diagnosis of infection (CDI). We systematically analyzed and investigated the performance of current laboratory diagnostic methods for CDI.
We performed systematic review and meta-analysis of studies in PubMed, Web of Science, Cochrane Library, and KoreaMed. The following methods were evaluated: glutamate dehydrogenase (GDH) enzyme immunoassays (GDH EIAs), toxin A and B detection by enzyme immunoassays (toxin AB EIAs), and nucleic acid amplification tests (NAATs) for toxin genes. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of each method were calculated.
Based on 39 studies, the pooled sensitivities/specificities were 92.7%/94.6%, 57.9%/97.0%, and 90.0%/95.8% for GDH EIAs, toxin AB EIAs, and NAATs, respectively, compared with those of toxigenic culture. The pooled sensitivities of automated EIAs were significantly higher than those of non-automated EIAs for both GDH and toxins A and B. The pooled sensitivity of Xpert was significantly higher than those of other NAATs. PPVs increased as CDI prevalence increased, and NPVs were excellent when CDI prevalence was low; at CDI prevalence of 5%, PPV=37%-65% and NPV=97%-100%; at CDI prevalence of 50%, PPV=92%-97% and NPV=65%-98%.
Toxin AB EIAs still show unsatisfactory sensitivity, whereas GDH EIAs and NAATs show relatively high sensitivity. However, toxin AB EIAs are the most specific tests. This study may provide useful information for CDI diagnosis.
有多种方法可用于感染（CDI）的诊断。我们系统地分析和研究了当前用于 CDI 的实验室诊断方法的性能。
我们在 PubMed、Web of Science、Cochrane Library 和 KoreaMed 中进行了系统的文献回顾和荟萃分析。评估了以下方法：谷氨酸脱氢酶（GDH）酶免疫分析（GDH EIA）、毒素 A 和 B 的酶免疫分析（毒素 AB EIA）以及毒素基因的核酸扩增检测（NAAT）。计算了每种方法的敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV）。
基于 39 项研究，GDH EIA、毒素 AB EIA 和 NAAT 的汇总敏感性/特异性分别为 92.7%/94.6%、57.9%/97.0%和 90.0%/95.8%，与产毒培养相比。自动 EIA 的汇总敏感性明显高于非自动 EIA 对 GDH 和毒素 A 和 B 的敏感性。Xpert 的汇总敏感性明显高于其他 NAAT。PPV 随着 CDI 患病率的增加而增加，而 NPV 在 CDI 患病率较低时则非常出色；在 CDI 患病率为 5%时，PPV=37%-65%，NPV=97%-100%；在 CDI 患病率为 50%时，PPV=92%-97%，NPV=65%-98%。
毒素 AB EIA 的敏感性仍然不理想，而 GDH EIA 和 NAAT 的敏感性相对较高。然而，毒素 AB EIA 是最特异的检测方法。本研究可为 CDI 的诊断提供有用的信息。
