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评估两种快速分子检测系统,以建立一种从阳性血培养物中快速鉴定细菌病原体的算法。

Evaluation of two rapid molecular test systems to establish an algorithm for fast identification of bacterial pathogens from positive blood cultures.

机构信息

Institute of Medical Microbiology and Hygiene, University of Tübingen, Elfriede-Aulhorn-Str. 6, 72076, Tübingen, Germany.

German Center for Infection Research (DZIF), Partner Site Tübingen, Tübingen, Germany.

出版信息

Eur J Clin Microbiol Infect Dis. 2020 Jun;39(6):1147-1157. doi: 10.1007/s10096-020-03828-5. Epub 2020 Feb 4.

Abstract

Fast identification of pathogens directly from positive blood cultures is of highest importance to supply an adequate therapy of bloodstream infections (BSI). There are several platforms providing molecular-based identification, detection of antimicrobial resistance genes, or even a full antimicrobial susceptibility testing (AST). Two of such test systems allowing rapid diagnostics were assessed in this study: The Biofire FilmArray® and the Genmark ePlex®, both fully automated test system with a minimum of hands-on time. Overall 137 BSI episodes were included in our study and compared to conventional culture-based reference methods. The FilmArray® is using one catridge including a panel for the most common bacterial and fungal BSI pathogens as well as selected resistance markers. The ePlex® offers three different cartridges for detection of Gram-positives, Gram-negatives, and fungi resulting in a broader panel including also rare pathogens, putative contaminants, and more genetic resistance markers. The FilmArray® and ePlex® were evaluated for all 137 BSI episodes with FilmArray® detecting 119 and ePlex® detecting 128 of these. For targets on the respective panel of the system, the FilmArray® generated a sensitivity of 98.9% with 100% specificity on Gram-positive isolates. The ePlex® system generated a sensitivity of 94.7% and a specificity of 90.7% on Gram-positive isolates. In each case, the two systems performed with 100% sensitivity and specificity for the detection of Gram-negative specimens covered by each panel. In summary, both evaluated test systems showed a satisfying overall performance for fast pathogen identification and are beneficial tools for accelerating blood culture diagnostics of sepsis patients.

摘要

快速鉴定阳性血培养物中的病原体对于提供血流感染(BSI)的适当治疗至关重要。有几种平台提供基于分子的鉴定、检测抗菌药物耐药基因,甚至是完整的抗菌药物敏感性测试(AST)。本研究评估了两种允许快速诊断的此类测试系统:Biofire FilmArray®和 Genmark ePlex®,这两种都是全自动测试系统,操作时间最短。总共纳入了 137 例 BSI 病例,并与传统的基于培养的参考方法进行比较。FilmArray® 使用一个试剂盒,其中包含用于最常见的细菌和真菌 BSI 病原体以及选定的耐药标记物的检测面板。ePlex® 提供三种不同的试剂盒,用于检测革兰氏阳性菌、革兰氏阴性菌和真菌,从而形成一个更广泛的检测面板,包括罕见病原体、可能的污染物和更多的遗传耐药标记物。FilmArray® 和 ePlex® 对所有 137 例 BSI 病例进行了评估,其中 FilmArray® 检测到 119 例,ePlex® 检测到 128 例。对于系统各自检测面板上的目标,FilmArray® 在革兰氏阳性菌分离物中产生了 98.9%的敏感性和 100%的特异性。ePlex® 系统在革兰氏阳性菌分离物中产生了 94.7%的敏感性和 90.7%的特异性。在每种情况下,这两个系统在检测每个面板涵盖的革兰氏阴性标本时,均表现出 100%的敏感性和特异性。总的来说,这两种评估的测试系统在快速鉴定病原体方面表现出令人满意的整体性能,是加速败血症患者血培养诊断的有益工具。

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