VITEK 2和VITEK 2 Compact系统对肠杆菌plazomicin药敏试验的性能评价

IF 5.4 2区 医学 Q1 MICROBIOLOGY
Journal of Clinical Microbiology Pub Date : 2025-09-10 Epub Date: 2025-08-01 DOI:10.1128/jcm.00449-25
Edith Csiki-Fejer, Maria Traczewski, Gary W Procop, Thomas E Davis, Meredith Hackel, Gilles Zambardi
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引用次数: 0

摘要

本研究的目的是在临床环境中使用VITEK 2和VITEK 2紧密型系统评估VITEK 2抗微生物药敏试验(AST)对革兰氏阴性(GN) plazomicin的性能,并证明其与临床和实验室标准协会(CLSI)肉汤微量稀释(BMD)技术的等效性。在四个外部地点进行的临床研究遵循了美国食品和药物管理局(FDA)和国际标准组织(ISO)指导文件的详细要求,包括临床、挑战、质量和可重复性研究。在这项多地点研究中,共检测了979株肠杆菌。VITEK 2卡最低抑制浓度(MIC)结果与参考BMD MIC结果进行比较。符合ISO标准的性能表明基本一致性(EA) = 97.8%,并且表明VITEK 2 plazomicin在肠杆菌中的MIC结果与CLSI BMD参考方法相比往往完全一致,除了大肠杆菌,当MIC倾向于完全一致或至少低一倍稀释时。根据FDA定义的断点进行分析:肠杆菌≤2个敏感(S), 4个中间(I)和≥8个耐药(R)。分析显示以下性能:EA = 98.7%,类别一致性(CA) = 99.4%,主要错误(ME) = 0.1%,无非常严重错误(VME)存在。有三种,肺炎克雷伯菌、大肠杆菌和粘质沙雷菌,其趋势≥30%,因此在美国标签中作为注释。plazomicin试验符合ISO和FDA标准,重复性≥95%,质量控制(QC)结果在QC生物可接受范围内。VITEK 2 AST- gn plazomicin检测是一种新的自动化替代BMD参考方法,用于测定肠杆菌的最低抑制浓度(MIC),扩大了自动AST检测的范围。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Performance evaluation of plazomicin susceptibility testing of Enterobacterales on VITEK 2 and VITEK 2 Compact Systems.

Performance evaluation of plazomicin susceptibility testing of Enterobacterales on VITEK 2 and VITEK 2 Compact Systems.

Performance evaluation of plazomicin susceptibility testing of Enterobacterales on VITEK 2 and VITEK 2 Compact Systems.

The objective of the present study was to evaluate the VITEK 2 antimicrobial susceptibility test (AST) for Gram-negative (GN) plazomicin performance using the VITEK 2 and VITEK 2 Compact Systems in clinical settings and to demonstrate its equivalence to the Clinical and Laboratory Standards Institute (CLSI) broth microdilution (BMD) technique. The clinical study conducted at four external sites followed the requirements detailed in the US Food and Drug Administration (FDA) and International Standards Organization (ISO) guidance documents and included clinical, challenge, quality, and reproducibility studies. In this multisite study, a total of 979 Enterobacterales isolates were tested. The VITEK 2 card minimum inhibitory concentration (MIC) results were compared with the reference BMD MIC results. The performance following ISO criteria indicated Essential Agreement (EA) = 97.8% and showed that VITEK 2 plazomicin MIC results for Enterobacterales tend to be in exact agreement when compared with the CLSI BMD reference method, except for Escherichia coli, when MICs tend to be in exact agreement or at least one doubling dilution lower. The analysis was also performed following the FDA criteria using the breakpoints defined by the FDA: ≤2 susceptible (S), 4 intermediate (I), and ≥8 resistant (R) for Enterobacterales. The analysis showed the following performance: EA = 98.7%, category agreement (CA) = 99.4%, and major errors (ME) = 0.1%, with no very major errors (VME) present. There are three species, Klebsiella pneumoniae, Escherichia coli, and Serratia marcescens, for which the trend is ≥ 30% and therefore addressed as a note in the US label. The plazomicin test met the ISO and FDA criteria of ≥95% reproducibility and ≥95% quality control (QC) results within acceptable ranges for QC organisms.IMPORTANCEThe VITEK 2 AST-GN plazomicin test is a new, automated alternative to the BMD reference method for determining minimum inhibitory concentrations (MIC) of Enterobacterales, expanding the range of automatic AST testing.

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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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