A multicenter evaluation of a novel microfluidic rapid AST assay for Gram-negative bloodstream infections.

IF 6.1 2区 医学 Q1 MICROBIOLOGY Journal of Clinical Microbiology Pub Date : 2024-10-16 Epub Date: 2024-09-26 DOI:10.1128/jcm.00458-24
Benjamin Berinson, Emma Davies, Jessie Torpner, Linnea Flinkfeldt, Jenny Fernberg, Amanda Åman, Johan Bergqvist, Håkan Öhrn, Jonas Ångström, Cecilia Johansson, Klara Jäder, Helena Andersson, Ehsan Ghaderi, Maria Rolf, Martin Sundqvist, Holger Rohde, Teresa Fernandez-Zafra, Christer Malmberg
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Abstract

Common phenotypic methods for antimicrobial susceptibility testing (AST) of bacteria are slow, labor intensive, and display considerable technical variability. The QuickMIC system provides rapid AST using a microfluidic linear gradient. Here, we evaluate the performance of QuickMIC at four different laboratories with regard to speed, precision, accuracy, and reproducibility in comparison to broth microdilution (BMD). Spiked (n = 411) and clinical blood cultures (n = 148) were tested with the QuickMIC Gram-negative panel and compared with BMD for the 12 on-panel antibiotics, and 10 defined strains were run at each site to measure reproducibility. Logistic and linear regression analysis was applied to explore factors affecting assay performance. The overall essential agreement and categorical agreement between QuickMIC and BMD were 95.6% and 96.0%, respectively. Very major error, major error, and minor error rates were 1.0%, 0.6%, and 2.4%, respectively. Inter-laboratory reproducibility between the sites was high at 98.9% using the acceptable standard of ±1 twofold dilution. The mean in-instrument analysis time overall was 3 h 13 min (SD: 29 min). Regression analysis indicated that QuickMIC is robust with regard to initial inoculum and delay time after blood culture positivity. We conclude that QuickMIC can be used to rapidly measure MIC directly from blood cultures in clinical settings with high reproducibility, precision, and accuracy. The microfluidics-generated linear gradient ensures high reproducibility between laboratories, thus allowing a high level of trust in MIC values from single testing, at the cost of reduced measurement range compared to BMD.

Importance: Increasing antimicrobial resistance underscores the need for new diagnostic solutions to guide therapy, but traditional antimicrobial susceptibility testing (AST) is often inadequate in time-critical diseases such as sepsis. This work presents a novel and rapid AST system with a rapid turnaround of results, which may help reduce the time to guided therapy, possibly allowing early de-escalation of broad-spectrum empirical therapy as well as rapid adjustments to treatments when coverage is lacking.

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针对革兰氏阴性血流感染的新型微流控快速 AST 检测法的多中心评估。
细菌抗菌药物敏感性测试 (AST) 的常见表型方法速度慢、劳动强度大,而且技术变异性很大。QuickMIC 系统利用微流体线性梯度提供快速 AST。与肉汤微量稀释法(BMD)相比,我们在此评估了 QuickMIC 在四个不同实验室的速度、精确度、准确性和可重复性方面的性能。使用 QuickMIC 革兰氏阴性菌检测板对加标(n = 411)和临床血液培养(n = 148)进行检测,并与肉汤微量稀释法(BMD)对检测板上的 12 种抗生素进行比较。采用逻辑和线性回归分析来探讨影响检测性能的因素。QuickMIC 和 BMD 的总体基本一致率和分类一致率分别为 95.6% 和 96.0%。极重大错误率、重大错误率和轻微错误率分别为 1.0%、0.6% 和 2.4%。采用±1两倍稀释的可接受标准,实验室之间的重现性高达98.9%。仪器内平均分析时间为 3 小时 13 分钟(标准偏差:29 分钟)。回归分析表明,QuickMIC 在初始接种量和血培养阳性后的延迟时间方面表现良好。我们的结论是,QuickMIC 可用于在临床环境中直接从血培养物中快速测量 MIC,并具有很高的重现性、精确性和准确性。微流控技术产生的线性梯度确保了实验室之间的高度可重复性,从而使单次检测的 MIC 值具有很高的可信度,但与 BMD 相比,测量范围有所缩小:抗菌药物耐药性的不断增加凸显了对新诊断解决方案的需求,以指导治疗,但传统的抗菌药物药敏试验(AST)在败血症等时间紧迫的疾病中往往无法满足需要。这项研究提出了一种新颖、快速的抗菌药物敏感性检测系统,该系统可快速得出检测结果,有助于缩短指导治疗的时间,从而有可能及早降低广谱经验疗法的等级,并在缺乏覆盖范围时快速调整治疗方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Clinical Microbiology
Journal of Clinical Microbiology 医学-微生物学
CiteScore
17.10
自引率
4.30%
发文量
347
审稿时长
3 months
期刊介绍: The Journal of Clinical Microbiology® disseminates the latest research concerning the laboratory diagnosis of human and animal infections, along with the laboratory's role in epidemiology and the management of infectious diseases.
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