Istituto di Microbiologia, Università Cattolica del Sacro Cuore, Rome, Italy.
Sezione di Igiene, Istituto di Sanità Pubblica, Università Cattolica del Sacro Cuore, Rome, Italy.
Clin Microbiol Infect. 2020 Mar;26(3):271-280. doi: 10.1016/j.cmi.2019.11.009. Epub 2019 Nov 18.
Timely detection of antimicrobial (cephalosporin/carbapenem) resistance (AMR) determinants is crucial to the clinical management of bloodstream infections caused by Gram-negative bacteria (GNB).
To review and meta-analyse the evidence for using commercially available molecular tests for the direct detection of AMR determinants in GNB-positive blood cultures (PBCs).
PubMed, Scopus and ISI Web of Knowledge.
Clinical studies evaluating the performance of two major commercial systems, namely the Verigene® and FilmArray® systems, for rapid testing of GNB-PBCs, in comparison with the phenotypic or genotypic methods performed on GNB-PBC isolates.
Literature search according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria and, for meta-analysis of sensitivity and specificity of both systems, bivariate random-effects model.
Twenty studies were identified (3310 isolates) from 2006 to 2019. Nine studies were conducted in East Asia. In 15 studies using phenotypic comparators (1930 isolates), 1014 (52.5%) isolates were Escherichia coli, and 287 (14.9%) of all the isolates displayed AMR phenotypes. In five studies using genotypic comparators (1380 isolates), 585 (42.4%) were E. coli, and 100 (7.2%) of all the isolates displayed AMR genotypes. Pooled sensitivity and specificity estimates for detection of AMR determinants by the Verigene (i.e. CTX-M, IMP, KPC, NDM, OXA and VIM) and/or FilmArray (i.e. KPC) systems were 85.3% (95% CI 79.9%-89.4%) and 99.1% (95% CI 98.2%-99.5%), respectively, across the 15 studies, and 95.5% (95% CI 89.2%-98.2%) and 99.7% (95% CI 99.1%-99.9%), respectively, across the five studies.
Our findings show that the Verigene and FilmArray systems may be a valid adjunct to the conventional microbiology (phenotypic or genotypic) methods used to identify AMR in GNBs. The FilmArray system detects only one AMR genotype, namely KPC, limiting its use. Both Verigene and FilmArray systems can miss important cephalosporin/carbapenem resistance phenotypes in a minority of cases. However, the sensitivity and specificity of both systems render them valuable clinical tools in timely identification of resistant isolates. Further studies will establish the prominence of such rapid diagnostics as standard of care in individuals with bloodstream infections.
及时检测抗菌药物（头孢菌素/碳青霉烯）耐药性（AMR）决定因素对于革兰氏阴性菌（GNB）引起的血流感染的临床管理至关重要。
综述并荟萃分析使用商业上可获得的分子检测直接检测 GNB 阳性血培养物（PBC）中 AMR 决定因素的证据。
PubMed、Scopus 和 ISI Web of Knowledge。
评估两种主要商业系统（即 Verigene®和 FilmArray®系统）在比较 GNB-PBC 分离物的表型或基因型方法时，对 GNB-PBC 快速检测性能的临床研究。
根据系统评价和荟萃分析的首选报告项目标准进行文献检索，对于两种系统的敏感性和特异性的荟萃分析，使用双变量随机效应模型。
从 2006 年至 2019 年共确定了 20 项研究（3310 株分离物），其中 9 项研究在东亚进行。在使用表型比较器（1930 株分离物）的 15 项研究中，1014（52.5%）株分离物为大肠杆菌，所有分离物中 287（14.9%）显示出 AMR 表型。在使用基因型比较器（1380 株分离物）的 5 项研究中，585（42.4%）株为大肠杆菌，所有分离物中 100（7.2%）显示出 AMR 基因型。通过 Verigene（即 CTX-M、IMP、KPC、NDM、OXA 和 VIM）和/或 FilmArray（即 KPC）系统检测 AMR 决定因素的汇总敏感性和特异性估计值分别为 85.3%（95%CI 79.9%-89.4%）和 99.1%（95%CI 98.2%-99.5%），跨越 15 项研究，分别为 95.5%（95%CI 89.2%-98.2%）和 99.7%（95%CI 99.1%-99.9%），跨越 5 项研究。
我们的研究结果表明，Verigene 和 FilmArray 系统可能是用于鉴定 GNB 中 AMR 的常规微生物学（表型或基因型）方法的有效辅助手段。FilmArray 系统仅检测一种 AMR 基因型，即 KPC，限制了其用途。Verigene 和 FilmArray 系统都可能在少数情况下错过重要的头孢菌素/碳青霉烯类耐药表型。然而，两种系统的敏感性和特异性都使它们成为及时鉴定耐药分离株的有价值的临床工具。进一步的研究将确定此类快速诊断在血流感染患者中的标准护理地位。
