艰难梭菌谷氨酸脱氢酶抗原及毒素检测试剂盒对艰难梭菌感染诊断价值的Meta分析
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茅一萍

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R446.5

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江苏省研究生科研与实践创新计划项目(KYCX18_2183)


Meta-analysis on diagnostic value of Clostridium difficile glutamate dehydrogenase antigen and toxin detection kit C. Diff Quik Chek Complete® in Clostridium difficile infection
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    摘要:

    目的 探讨艰难梭菌谷氨酸脱氢酶(GDH)抗原及毒素检测试剂盒(简称CD快速检测试剂盒)对艰难梭菌感染(CDI)的诊断价值。方法 按照纳入和排除标准筛选文献,检索有关CD快速检测试剂盒诊断CDI的文献,采用诊断准确性研究的质量评价工具QUADAS进行质量评价,应用Meta DiSc 1.4软件进行Meta分析。结果 共纳入8篇文献2 852例研究对象。纳入文献均为高质量文献,异质性检验显示无阈值效应,但存在其他原因导致的非阈值性异质性。采用随机效应模型进行Meta分析,结果显示,CD快速检测试剂盒GDH抗原检测诊断CDI的合并灵敏度、特异度、阳性似然比、阴性似然比、诊断优势比及其95%CI分别为0.96(0.94,0.98)、0.96(0.95,0.97)、20.07(13.47,29.92)、0.04(0.03,0.07)、409.35(168.01,997.39);毒素检测诊断CDI分别为0.54(0.48,0.59)、1.00(0.99, 1.00)、64.23(18.90,218.33)、0.48(0.37,0.62)、142.74(40.94,497.61)。试剂盒GDH抗原、毒素检测诊断CDI的受试者工作曲线下面积(AUCSROC)分别为0.9877、0.9529,Q*指数分别为0.9718、0.9228。结论 CD快速检测试剂盒抗原检测部分灵敏度、特异度、阳性似然比、阴性似然比及诊断优势比均较高,毒素检测部分虽灵敏度欠佳,但特异度较高,可作为缺乏专业设备条件的地区及医院CDI的初筛试剂盒。

    Abstract:

    Objective To explore the diagnostic value of Clostridium difficile (C. difficile) glutamate dehydrogenase (GDH) antigen and toxin detection kit (C. Diff Quik Chek Complete®) in C. difficile infection (CDI). Methods Literatures were screened according to inclusion and exclusion criteria, literatures about CDI diagnosed by C. Diff Quik Chek Complete® were retrieved, quality assessment tool QUADAS for diagnostic accuracy research was used to perform quality evaluation, Meta-DiSc 1.4 software was used to conduct Meta-analysis. Results A total of 8 literatures and 2 852 research subjects were included in the study. The included literatures are of high quality, heterogeneity test showed that there was no threshold effect, but there was non-threshold heterogeneity due to other causes. Meta-analysis was performed with random effect model, results showed that the combined sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, diagnostic dominance ratio (95% CI) of diagnosis of CDI through C. Diff Quik Chek Complete® GDH antigen detection were 0.96 (0.94, 0.98), 0.96 (0.95, 0.97), 20.07 (13.47, 29.92), 0.04 (0.03, 0.07), and 409.35 (168.01, 997.39) respectively; toxin detection for diagnosis of CDI were 0.54 (0.48, 0.59), 1.00 (0.99, 1.00), 64.23 (18.90, 218.33), 0.48 (0.37, 0.62), and 142.74 (40.94, 497.61) respectively. The area under the summary receiver operating characteristic curve (AUCSROC) of GDH antigen and toxin detection for diagnosis of CDI were 0.9877 and 0.9529 respectively, and Q* index were 0.9718 and 0.9228 respectively. Conclusion The sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and diagnostic dominance ratio of antigen detection by C. Diff Quik Chek Complete® are high, although the sensitivity of toxin detection is not perfect, its specificity is high, which can be used as the primary screening kit for CDI in areas and hospitals lacking professional equipment and conditions.

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祁琪, 茅一萍, 李阳,等.艰难梭菌谷氨酸脱氢酶抗原及毒素检测试剂盒对艰难梭菌感染诊断价值的Meta分析[J]. 中国感染控制杂志,2019,18(6):511-518. DOI:10.12138/j. issn.1671-9638.20195333.
QI Qi, MAO Yi-ping, LI Yang, et al. Meta-analysis on diagnostic value of Clostridium difficile glutamate dehydrogenase antigen and toxin detection kit C. Diff Quik Chek Complete® in Clostridium difficile infection[J]. Chin J Infect Control, 2019,18(6):511-518. DOI:10.12138/j. issn.1671-9638.20195333.

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  • 收稿日期:2019-04-15
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  • 在线发布日期: 2019-06-28
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