使用BD Phoenix™ NMIC - 413抗菌药物敏感性检测板对耐碳青霉烯类和耐碳青霉烯类进行四种抗生素的性能评估。 （注：原文中“carbapenem-resistant and carbapenem-resistant”表述重复，疑似有误，但按要求进行了翻译）
Performance evaluation of four antibiotics using the BD Phoenix™ NMIC-413 antimicrobial susceptibility testing panel for carbapenem-resistant and carbapenem-resistant .
作者信息
Guan Yajuan, Song Zhenli, Chen Yanshan, Feng Jiayu, Fan Yizhi, Rui Yongyu
机构信息
Department of Laboratory Medicine, Guangdong Provincial Key Laboratory of Precision Medical Diagnostics, Guangdong Engineering and Technology Research Center for Rapid Diagnostic Biosensors, Guangdong Provincial Key Laboratory of Single-cell and Extracellular Vesicles, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Guangdong Provincial Clinical Research Center for Laboratory Medicine, Guangzhou, China.
出版信息
Front Microbiol. 2025 Jul 4;16:1593674. doi: 10.3389/fmicb.2025.1593674. eCollection 2025.
BACKGROUND
The spread of antimicrobial resistance (AMR) poses significant threats to human health. In 2024, the World Health Organization (WHO) classified carbapenem-resistant (CRE) as a critical-priority pathogen and carbapenem-resistant (CRPA) as a high-priority pathogen. This study aimed to evaluate the performance of meropenem (MEM), imipenem (IPM), cefepime (FEP), and cefoperazone/sulbactam (SCF) using the BD Phoenix™ NMIC-413 antimicrobial susceptibility testing (AST) panel (NMIC-413 panel) for CRE and CRPA at Nanfang Hospital, China.
METHODS
A total of 314 archived Gram-negative clinical isolates were tested, including 219 isolates (150 CRE) and 95 isolates (56 CRPA). The NMIC-413 panel and the disk diffusion method were employed for AST of MEM, IPM, FEP, and SCF. Broth microdilution (BMD) was used as the reference method. Categorical agreement (CA), essential agreement (EA), very major errors (VME), major errors (ME), and minor errors (MIE) were calculated. The acceptable standards were as follows: CA and EA > 90%, ME < 3%, and VME < 1.5%.
RESULTS
For CRE, the NMIC-413 panel met the acceptable standards and demonstrated higher CA values than the disk diffusion method for all four antibiotics (99.3, 96.6, 98.0, and 98.7% vs. 98.7, 96.0, 96.0, and 97.3%, respectively). For CRPA, the NMIC-413 panel also met the acceptable standards and showed superior CA values for MEM and FEP compared to the disk diffusion method (98.2 and 96.4% vs. 96.4 and 92.9%, respectively), while CA values for IPM and SCF were similar between the two methods (98.2 and 92.9% vs. 98.2 and 92.9%, respectively).
CONCLUSION
The NMIC-413 panel demonstrated Clinical Laboratory Standards Institute (CLSI)-compliant performance for all four tested antibiotics against CRE and CRPA, exhibiting superior reliability compared to the conventional disk diffusion method. Future studies should focus on establishing standardized breakpoints for SCF, expanding the detection spectrum for rare bacterial species, and conducting multicenter validation to assess regional variations. We recommend the NMIC-413 panel for AST of CRE and CRPA isolates as a practical alternative to the BMD method.
背景
抗菌药物耐药性（AMR）的传播对人类健康构成重大威胁。2024年，世界卫生组织（WHO）将耐碳青霉烯类肠杆菌科细菌（CRE）列为关键优先病原体，将耐碳青霉烯类铜绿假单胞菌（CRPA）列为高优先病原体。本研究旨在使用BD Phoenix™ NMIC - 413抗菌药物敏感性试验（AST）检测板（NMIC - 413检测板）评估美罗培南（MEM）、亚胺培南（IPM）、头孢吡肟（FEP）和头孢哌酮/舒巴坦（SCF）对中国南方医院CRE和CRPA的检测性能。
方法
共检测314株存档的革兰阴性临床分离株，包括219株（150株CRE）和95株（56株CRPA）。采用NMIC - 413检测板和纸片扩散法对MEM、IPM、FEP和SCF进行AST检测。肉汤微量稀释法（BMD）用作参考方法。计算分类一致性（CA）、必需一致性（EA）、极重大错误（VME）、重大错误（ME）和微小错误（MIE）。可接受标准如下：CA和EA > 90%，ME < 3%，VME < 1.5%。
结果
对于CRE，NMIC - 413检测板符合可接受标准，并且在所有四种抗生素中显示出比纸片扩散法更高的CA值（分别为99.3%、96.6%、98.0%和98.7%，对比98.7%、96.0%、96.0%和97.3%）。对于CRPA，NMIC - 413检测板也符合可接受标准，与纸片扩散法相比，MEM和FEP的CA值更高（分别为98.2%和96.4%，对比96.4%和92.9%），而IPM和SCF在两种方法中的CA值相似（分别为98.2%和92.9%，对比98.2%和92.9%）。
结论
NMIC - 413检测板对所有四种测试抗生素检测CRE和CRPA的性能符合临床实验室标准协会（CLSI）要求，与传统纸片扩散法相比具有更高的可靠性。未来研究应专注于建立SCF的标准化断点，扩大对罕见细菌种类的检测谱，并进行多中心验证以评估区域差异。我们推荐使用NMIC - 413检测板对CRE和CRPA分离株进行AST检测，作为BMD方法的实用替代方法。
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