First description of the performance of the VITEK MITUBE device used with MALDI-TOF mass spectrometry to achieve identification of gram-negative bacteria directly from positive blood culture broth.

IF 5.4 2区 医学 Q1 MICROBIOLOGY
Journal of Clinical Microbiology Pub Date : 2025-08-13 Epub Date: 2025-07-18 DOI:10.1128/jcm.00122-25
Daniel D Rhoads, Nancy D Hanson, Kaley Reedy, Johanne Gafsi, Yun X Ying, Dwight J Hardy
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引用次数: 0

Abstract

Improving the rapidity of identification of bacteria causing bacteremia continues to be a focus for quality improvement within the discipline of clinical microbiology. This multicenter study was used to obtain In Vitro Diagnostic Regulation Conformite Europeenne (CE) mark in Europe and describes the performance of the VITEK MITUBE to matrix-assisted laser desorption/ionization (MALDI) workflow for identification of 10 species of gram-negative bacteria directly from positive blood culture broth without subculture. One hundred twenty-five (125) prospective clinical samples, including Escherichia coli (69), Klebsiella aerogenes (4), Klebsiella oxytoca (3), Klebsiella pneumoniae (29), Proteus mirabilis (9), Pseudomonas aeruginosa (10), and Serratia marcescens (1), were included; and 123 (98.4%) were accurately identified using the VITEK MITUBE workflow. None were misidentified, and two (1.6%) K. pneumoniae were not identified. Contrived samples were also tested and reported in this study. When considering both the prospective clinical samples and the contrived samples, the workflow was able to identify the species 95% of the time. Proteus vulgaris accounted for 81% (13/16) of the samples that were unable to achieve an identification. A single misidentification error is reported in the contrived sample testing. The VITEK MITUBE to MALDI workflow enables accurate and reliable identification of commonly encountered gram-negative bacteria directly from positive blood culture broth.IMPORTANCEMITUBE is a new in vitro diagnostic device designed to meet a need in the clinical microbiology community for a simple, rapid, accurate, and inexpensive system to identify bacteria detected in blood cultures using MALDI-TOF and without the need for subculture.

首先描述了VITEK MITUBE设备与MALDI-TOF质谱一起使用的性能,可以直接从阳性血液培养肉汤中鉴定革兰氏阴性细菌。
提高鉴定引起菌血症的细菌的速度仍然是临床微生物学学科质量改进的重点。这项多中心研究用于获得欧洲体外诊断规范合格(CE)标志,并描述了VITEK MITUBE到基质辅助激光解吸/电离(MALDI)工作流程的性能,该工作流程可直接从阳性血培养液中鉴定10种革兰氏阴性菌,而无需传代培养。125份前瞻性临床样本,包括大肠杆菌(69)、产气克雷伯菌(4)、产氧克雷伯菌(3)、肺炎克雷伯菌(29)、变形杆菌(9)、铜绿假单胞菌(10)和粘质沙雷菌(1);使用VITEK MITUBE工作流程准确识别123例(98.4%)。无误诊,2例(1.6%)肺炎克雷伯菌未确诊。本研究还对人造样品进行了测试和报告。当考虑到预期临床样本和人工样本时,该工作流程能够在95%的时间内识别物种。无法鉴定的样品中,普通变形杆菌占81%(13/16)。在人造样品测试中报告了一个单一的误识别错误。VITEK MITUBE to MALDI工作流程能够直接从阳性血液培养肉汤中准确可靠地鉴定常见的革兰氏阴性细菌。重要意义emitube是一种新的体外诊断设备,旨在满足临床微生物学社区对使用MALDI-TOF识别血液培养中检测到的细菌的简单,快速,准确和廉价的系统的需求,无需传代培养。
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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