Suppr超能文献

多中心评价 Selux 下一代表型药敏检测系统。

Multicenter evaluation of the Selux Next-Generation Phenotyping antimicrobial susceptibility testing system.

机构信息

Selux Diagnostics, Charlestown, Massachusetts, USA.

Pathology and Laboratory Medicine, Loyola University Medical Center, Maywood, Illinois, USA.

出版信息

J Clin Microbiol. 2024 Jan 17;62(1):e0054623. doi: 10.1128/jcm.00546-23. Epub 2023 Dec 5.

Abstract

The Selux Next-Generation Phenotyping (NGP) system (Charlestown, MA) is a new antimicrobial susceptibility testing system that utilizes two sequential assays performed on all wells of doubling dilution series to determine MICs. A multicenter evaluation of the performance of the Selux NGP system compared with reference broth microdilution was conducted following FDA recommendations and using FDA-defined breakpoints. A total of 2,488 clinical and challenge isolates were included; gram-negative isolates were tested against 24 antimicrobials, and gram-positive isolates were tested against 15 antimicrobials. Data is provided for all organism-antimicrobial combinations evaluated, including those that did and did not meet FDA performance requirements. Overall very major error and major error rates were less than 1% (31/3,805 and 107/15,606, respectively), essential agreement and categorical agreement were >95%, reproducibility was ≥95%, and the average time-to-result (from time of assay start to time of MIC result) was 5.65 hours.

摘要

Selux 下一代表型检测(NGP)系统(马萨诸塞州查尔斯顿)是一种新的抗菌药物敏感性测试系统,它利用在所有倍比稀释系列孔中进行的两个连续检测来确定 MIC 值。根据 FDA 的建议并使用 FDA 定义的折点,对 Selux NGP 系统与参考肉汤微量稀释法的性能进行了多中心评估。共纳入了 2488 例临床和挑战性分离株;革兰氏阴性分离株检测了 24 种抗菌药物,革兰氏阳性分离株检测了 15 种抗菌药物。提供了所有评估的生物体-抗菌药物组合的数据,包括符合和不符合 FDA 性能要求的组合。总体上,非常大错误和主要错误率低于 1%(分别为 31/3805 和 107/15606),基本一致性和分类一致性>95%,重现性≥95%,平均结果时间(从检测开始到 MIC 结果时间)为 5.65 小时。

相似文献

1
Multicenter evaluation of the Selux Next-Generation Phenotyping antimicrobial susceptibility testing system.
J Clin Microbiol. 2024 Jan 17;62(1):e0054623. doi: 10.1128/jcm.00546-23. Epub 2023 Dec 5.
5
Validation of EUCAST zone diameter breakpoints against reference broth microdilution.
Clin Microbiol Infect. 2014 Jun;20(6):O353-60. doi: 10.1111/1469-0691.12414. Epub 2013 Nov 13.
10

本文引用的文献

2
Antimicrobial Susceptibility Testing: A Comprehensive Review of Currently Used Methods.
Antibiotics (Basel). 2022 Mar 23;11(4):427. doi: 10.3390/antibiotics11040427.
4
Raising the Bar: Improving Antimicrobial Resistance Detection by Clinical Laboratories by Ensuring Use of Current Breakpoints.
Open Forum Infect Dis. 2022 Feb 7;9(3):ofac007. doi: 10.1093/ofid/ofac007. eCollection 2022 Mar.
5
Current State of Laboratory Automation in Clinical Microbiology Laboratory.
Clin Chem. 2021 Dec 30;68(1):99-114. doi: 10.1093/clinchem/hvab242.
6
Recent advances in rapid antimicrobial susceptibility testing systems.
Expert Rev Mol Diagn. 2021 Jun;21(6):563-578. doi: 10.1080/14737159.2021.1924679. Epub 2021 May 20.
7
Innovative and rapid antimicrobial susceptibility testing systems.
Nat Rev Microbiol. 2020 May;18(5):299-311. doi: 10.1038/s41579-020-0327-x. Epub 2020 Feb 13.
8
Broad-spectrum antibiotic use and poor outcomes in community-onset pneumonia: a cohort study.
Eur Respir J. 2019 Jul 4;54(1). doi: 10.1183/13993003.00057-2019. Print 2019 Jul.
9
Microplate-based surface area assay for rapid phenotypic antibiotic susceptibility testing.
Sci Rep. 2019 Jan 18;9(1):237. doi: 10.1038/s41598-018-35916-0.
10
The Slow March toward Rapid Phenotypic Antimicrobial Susceptibility Testing: Are We There Yet?
J Clin Microbiol. 2018 Mar 26;56(4). doi: 10.1128/JCM.01999-17. Print 2018 Apr.

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验