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使用更新后的断点评估MicroScan和VITEK 2系统对肠杆菌科细菌进行药敏试验的情况。

Evaluation of MicroScan and VITEK 2 systems for susceptibility testing of Enterobacterales with updated breakpoints.

作者信息

Richter Sandra S, Dominguez Elizabeth L, Hupp Aaron A, Griffis Matt, MacVane Shawn H

机构信息

Department of Laboratory Medicine and Pathology, Mayo Clinic, Jacksonville, Florida, USA.

bioMerieux, Inc., Hazelwood, Missouri, USA.

出版信息

J Clin Microbiol. 2025 Jun 11;63(6):e0004825. doi: 10.1128/jcm.00048-25. Epub 2025 Apr 30.

Abstract

We compared the performance of two commercial antimicrobial susceptibility testing (AST) systems for contemporary Enterobacterales strains using broth microdilution (BMD) as the reference standard with 2022 Clinical and Laboratory Standards Institute or current FDA breakpoints applied. Enterobacterales clinical isolates with BMD results were tested in parallel using VITEK 2 AST test cards (N802, XN15, bioMérieux, Hazelwood, MO, USA) and MicroScan NM56 AST panels (Beckman Coulter, Sacramento, CA, USA). The 200 isolates (57 , 55 , 21 complex, 18 , 12 , 10 , 9 , 8 , 5 , 3 , and 2 ) included 25% extended-spectrum beta-lactamase (ESBL), 23% carbapenem-resistant Enterobacterales (CRE), and 4.5% AmpC resistance phenotypes. For the 28 antimicrobial agents tested, essential agreement (EA, MIC within ±1 doubling dilution), categorical agreement (CA, same categorical interpretation: susceptible, intermediate, susceptible dose dependent, and resistant), and error rates were calculated using BMD as the reference standard. Time to results (TTR) was determined for each instrument for all 200 isolates. Hands-on time was assessed by timing two technologists each setting up six batches of five isolates on each system. Accuracy was similar between systems with an overall CA > 94% and EA ≥ 96%. The CA was ≥90% for most agents tested on both systems (exceptions were ampicillin-sulbactam, cefoxitin, minocycline, and nitrofurantoin). The MicroScan with Prompt inoculum preparation required less hands-on setup time than VITEK (1.29 vs 1.83 min/isolate). The median instrument TTR was less for VITEK (11.7 vs 18 hours, < 0.001), yielding an overall faster turnaround time.IMPORTANCEThere are limited data directly comparing the performance of commercial antimicrobial susceptibility testing systems for contemporary bacterial strains using the Clinical and Laboratory Standards Institute broth microdilution method as the reference standard and applying updated breakpoints. These data will hopefully encourage labs to perform the necessary verification or validation studies needed to implement current breakpoints and ensure antimicrobial resistance is detected.

摘要

我们使用肉汤微量稀释法(BMD)作为参考标准,并应用2022年临床和实验室标准协会(Clinical and Laboratory Standards Institute)或美国食品药品监督管理局(FDA)当前的折点,比较了两种商业抗菌药物敏感性试验(AST)系统对当代肠杆菌科菌株的性能表现。对具有BMD结果的肠杆菌科临床分离株,使用VITEK 2 AST测试卡(N802、XN15,法国生物梅里埃公司,美国密苏里州黑兹尔伍德)和MicroScan NM56 AST检测板(美国加利福尼亚州萨克拉门托的贝克曼库尔特公司)进行平行检测。这200株分离株(分别为57株、55株、21株复合菌、18株、12株、10株、9株、8株、5株、3株和2株)包括25%的产超广谱β-内酰胺酶(ESBL)菌株、23%的耐碳青霉烯类肠杆菌科(CRE)菌株以及4.5%的AmpC耐药表型。对于所检测的28种抗菌药物,以BMD作为参考标准计算基本一致性(EA,MIC在±1倍稀释范围内)、分类一致性(CA,相同的分类解释:敏感、中介、剂量依赖性敏感和耐药)以及错误率。测定了所有200株分离株在每种仪器上的报告结果时间(TTR)。通过记录两名技术人员在每个系统上各设置六批、每批五株分离株的操作时间来评估实际操作时间。两个系统的准确性相似,总体CA>94%,EA≥96%。在两个系统上检测的大多数药物的CA≥90%(氨苄西林-舒巴坦、头孢西丁、米诺环素和呋喃妥因除外)。配备快速接种准备功能的MicroScan系统所需的实际操作设置时间比VITEK系统少(1.29分钟/株对1.83分钟/株)。VITEK系统的仪器TTR中位数更低(11.7小时对18小时,P<0.001),总体周转时间更快。

重要性

直接比较商业抗菌药物敏感性试验系统对当代细菌菌株的性能表现,以临床和实验室标准协会肉汤微量稀释法作为参考标准并应用更新后的折点的数据有限。这些数据有望鼓励实验室开展实施当前折点所需的必要验证研究,并确保检测到抗菌药物耐药性。

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