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五种检测碳青霉烯酶方法的比较评估及其精确应用方案的提出。

Comparative Evaluation of Five Assays for Detection of Carbapenemases with a Proposed Scheme for Their Precise Application.

机构信息

Department of Infectious Diseases, Graduate School of Medicine, International University of Health and Welfare, Narita, Japan; Department of Pharmacology, Faculty of Veterinary Medicine, Kafrelsheikh University, Kafr El-Sheikh, Egypt.

Department of Microbiology, St. Marianna University School of Medicine, Kawasaki, Japan.

出版信息

J Mol Diagn. 2020 Sep;22(9):1129-1138. doi: 10.1016/j.jmoldx.2020.05.012. Epub 2020 Jun 15.

Abstract

The escalating problem of the dissemination of carbapenemase-producing bacteria (CPB) has gained worldwide attention. The prompt diagnosis of CPB and precise identification of carbapenemases are imperative to enable specific antibiotic therapy and control the spread of these bacteria. The present study was designed to assess the performance of five important assays for the detection of carbapenemases. The modified carbapenem inactivation method (mCIM), CARBA-5, GeneXpert Carba-R, BD MAX Check-Points CPO, and GeneFields CPE assays were evaluated with an international collection of 159 bacterial isolates, including 93 CPB and 66 non-CPB isolates. The overall accuracy/sensitivity/specificity for carbapenemase detection were 100% (95% CI, 97.7%-100%)/100% (95% CI, 96.1%-100%)/100% (95% CI, 94.6%-100%) for mCIM, 98.7% (95% CI, 95.5%-99.9%)/97.9% (95% CI, 92.5%-99.7%)/100% (95% CI, 94.6%-100%) for CARBA-5, 96.9% (95% CI, 92.8%-99%)/95.7% (95% CI, 89.4%-98.8%)/98.5% (95% CI, 91.8%-99.9%) for GeneXpert Carba-R, 94.3% (95% CI, 89.5%-97.4%)/90.3% (95% CI, 82.4%-95.5%)/100% (95% CI, 94.6%-100%) for BD MAX Check-Points CPO, and 86.2% (95% CI, 79.8%-91.1%)/77.4% (95% CI, 67.6%-85.5%)/98.5% (95% CI, 91.8%-100%) for GeneFields CPE. Interestingly, mCIM and CARBA-5 assays showed 100% accuracy/sensitivity/specificity for detection of the target genes. Furthermore, all the other assays showed comparable high accuracy (96.9% to 100%), sensitivity (100%), and specificity (96.4% to 100%) for the detection of the target genes. On the basis of these results, a new scheme was proposed for their efficient application. These results confirmed the high sensitivity of the evaluated assays, and the proposed scheme is reliable and improves the overall sensitivity and specificity of the assays.

摘要

产碳青霉烯酶细菌(CPB)传播问题日益严重,引起了全球关注。及时诊断 CPB 并准确识别碳青霉烯酶对于实施特定抗生素治疗和控制这些细菌的传播至关重要。本研究旨在评估五种重要检测碳青霉烯酶的方法的性能。采用改良碳青霉烯灭活法(mCIM)、CARBA-5、GeneXpert Carba-R、BD MAX Check-Points CPO 和 GeneFields CPE 检测法,对包括 93 株 CPB 和 66 株非 CPB 在内的 159 株细菌分离株的国际样本进行了评估。mCIM 的碳青霉烯酶检测总准确性/敏感性/特异性为 100%(95%CI,97.7%-100%)/100%(95%CI,96.1%-100%)/100%(95%CI,94.6%-100%);CARBA-5 为 98.7%(95%CI,95.5%-99.9%)/97.9%(95%CI,92.5%-99.7%)/100%(95%CI,94.6%-100%);GeneXpert Carba-R 为 96.9%(95%CI,92.8%-99%)/95.7%(95%CI,89.4%-98.8%)/98.5%(95%CI,91.8%-99.9%);BD MAX Check-Points CPO 为 94.3%(95%CI,89.5%-97.4%)/90.3%(95%CI,82.4%-95.5%)/100%(95%CI,94.6%-100%);GeneFields CPE 为 86.2%(95%CI,79.8%-91.1%)/77.4%(95%CI,67.6%-85.5%)/98.5%(95%CI,91.8%-100%)。有趣的是,mCIM 和 CARBA-5 检测法对目标基因的检测具有 100%的准确性/敏感性/特异性。此外,其他所有检测法对目标基因的检测均具有相当高的准确性(96.9%至 100%)、敏感性(100%)和特异性(96.4%至 100%)。基于这些结果,提出了一种新的方案来高效应用这些检测法。这些结果证实了评估检测法的高灵敏度,所提出的方案可靠,提高了检测法的整体灵敏度和特异性。

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