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评价 QMAC-dRAST 系统版本 2.5 对阳性血培养肉汤和分离培养菌落的革兰氏阴性菌进行快速抗菌药物敏感性测试的效果。

Evaluation of the QMAC-dRAST System Version 2.5 for Rapid Antimicrobial Susceptibility Testing of Gram-Negative Bacteria From Positive Blood Culture Broth and Subcultured Colony Isolates.

机构信息

Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.

Biomedical Engineering Research Center, Smart Healthcare Research Institute, Samsung Medical Center, Seoul, Republic of Korea.

出版信息

J Clin Lab Anal. 2024 May;38(9):e25043. doi: 10.1002/jcla.25043. Epub 2024 May 28.

Abstract

BACKGROUND

Rapid antimicrobial susceptibility testing (AST) for bloodstream infections (BSIs) facilitates the optimization of antimicrobial therapy, preventing antimicrobial resistance and improving patient outcomes. QMAC-dRAST (QuantaMatrix Inc., Korea) is a rapid AST platform based on microfluidic chip technology that performs AST directly using positive blood culture broth (PBCB). This study evaluated the performance of QMAC-dRAST for Gram-negative bacteria using PBCB and subcultured colony isolates, comparing it with that of VITEK 2 (bioMérieux, France) using broth microdilution (BMD) as the reference method.

METHODS

We included 141 Gram-negative blood culture isolates from patients with BSI and 12 carbapenemase-producing clinical isolates of Enterobacterales spiked into blood culture bottles. QMAC-dRAST performance was evaluated using PBCB and colony isolates, whereas VITEK 2 and BMD were tested only on colony isolates.

RESULTS

For PBCB, QMAC-dRAST achieved 92.1% categorical agreement (CA), 95.3% essential agreement (EA), with 1.8% very major errors (VMEs), 3.5% major errors (MEs), and 5.2% minor errors (mEs). With colony isolates, it exhibited 92.5% CA and 95.1% EA, with 2.0% VMEs, 3.2% MEs, and 4.8% mEs. VITEK 2 showed 94.1% CA and 96.0% EA, with 4.3% VMEs, 0.4% MEs, and 4.3% mEs. QMAC-dRAST yielded elevated error rates for specific antimicrobial agents, with high VMEs for carbapenems and aminoglycosides. The median time to result for QMAC-dRAST was 5.9 h for PBCB samples and 6.1 h for subcultured colony isolates.

CONCLUSIONS

The QMAC-dRAST system demonstrated considerable strengths and comparable performance to the VITEK 2 system; however, challenges were discerned with specific antimicrobial agents, underlining a necessity for improvement.

摘要

背景

快速抗菌药敏试验(AST)可优化血流感染(BSI)的抗菌治疗,防止抗菌耐药,并改善患者结局。QMAC-dRAST(韩国 QuantaMatrix 公司)是一种基于微流控芯片技术的快速 AST 平台,它直接使用阳性血培养肉汤(PBCB)进行 AST。本研究使用肉汤微量稀释法(BMD)作为参考方法,评估了 QMAC-dRAST 对革兰氏阴性菌使用 PBCB 和培养菌落分离物的性能,并与 VITEK 2(法国 bioMérieux)进行了比较。

方法

我们纳入了 141 株来自 BSI 患者的革兰氏阴性血培养分离株和 12 株耐碳青霉烯肠杆菌科临床分离株,这些分离株在血培养瓶中被添加。使用 PBCB 和菌落分离物评估 QMAC-dRAST 的性能,而 VITEK 2 和 BMD 仅在菌落分离物上进行测试。

结果

对于 PBCB,QMAC-dRAST 实现了 92.1%的分类一致性(CA)和 95.3%的基本一致(EA),有 1.8%的非常大误差(VME)、3.5%的主要误差(ME)和 5.2%的次要误差(mE)。使用菌落分离物时,其 CA 为 92.5%,EA 为 95.1%,VME 为 2.0%,ME 为 3.2%,mE 为 4.8%。VITEK 2 显示出 94.1%的 CA 和 96.0%的 EA,VME 为 4.3%,ME 为 0.4%,mE 为 4.3%。QMAC-dRAST 对特定抗菌药物的错误率较高,碳青霉烯类和氨基糖苷类药物的 VME 较高。对于 PBCB 样本,QMAC-dRAST 的中位结果时间为 5.9 小时,对于培养的菌落分离物为 6.1 小时。

结论

QMAC-dRAST 系统显示出相当大的优势和与 VITEK 2 系统相当的性能;然而,在某些特定的抗菌药物方面存在挑战,突显了改进的必要性。

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