Table 1_Performance evaluation of four antibiotics using the BD Phoenix™ NMIC-413 antimicrobial susceptibility testing panel for carbapenem-resistant Enterobacteriaceae and carbapenem-resistant Pseudomonas aeruginosa.xlsx

BackgroundThe spread of antimicrobial resistance (AMR) poses significant threats to human health. In 2024, the World Health Organization (WHO) classified carbapenem-resistant Enterobacteriaceae (CRE) as a critical-priority pathogen and carbapenem-resistant Pseudomonas aeruginosa (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.
MethodsA total of 314 archived Gram-negative clinical isolates were tested, including 219 Enterobacteriaceae isolates (150 CRE) and 95 P. aeruginosa 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%.
ResultsFor 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).
ConclusionThe 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（antimicrobial resistance, AMR）的传播对人类健康构成严重威胁。2024年，世界卫生组织（World Health Organization, WHO）将碳青霉烯类耐药肠杆菌科（carbapenem-resistant Enterobacteriaceae, CRE）列为最高优先级病原体，将碳青霉烯类耐药铜绿假单胞菌（carbapenem-resistant Pseudomonas aeruginosa, CRPA）列为高优先级病原体。本研究旨在评估BD Phoenix™ NMIC-413抗菌药物敏感性试验（antimicrobial susceptibility testing, AST）试剂盒（以下简称NMIC-413试剂盒）在中国南方医院针对CRE和CRPA的美罗培南（meropenem, MEM）、亚胺培南（imipenem, IPM）、头孢吡肟（cefepime, FEP）及头孢哌酮/舒巴坦（cefoperazone/sulbactam, SCF）的检测性能。
方法：本研究共纳入314株存档的革兰阴性临床分离株，其中包括219株肠杆菌科分离株（含150株CRE）及95株铜绿假单胞菌分离株（含56株CRPA）。采用NMIC-413试剂盒与纸片扩散法开展MEM、IPM、FEP及SCF的抗菌药物敏感性试验，以肉汤微量稀释法（Broth microdilution, BMD）作为参考方法。计算分类一致率（Categorical agreement, CA）、基本一致率（essential agreement, EA）、极严重错误（very major errors, VME）、严重错误（major errors, ME）及轻微错误（minor errors, MIE）。可接受标准如下：CA与EA>90%，ME<3%，VME<1.5%。
结果：针对CRE，NMIC-413试剂盒符合可接受标准，且针对四种抗菌药物的分类一致率均高于纸片扩散法（分别为99.3%、96.6%、98.0%、98.7% vs 98.7%、96.0%、96.0%、97.3%）。针对CRPA，NMIC-413试剂盒同样符合可接受标准，针对MEM与FEP的分类一致率优于纸片扩散法（分别为98.2%、96.4% vs 96.4%、92.9%）；而针对IPM与SCF，两种方法的分类一致率无显著差异（均为98.2%、92.9%）。
结论：NMIC-413试剂盒针对四种受试抗菌药物的CRE与CRPA检测性能均符合临床和实验室标准协会（Clinical Laboratory Standards Institute, CLSI）的合规要求，且相较于传统纸片扩散法具有更优异的可靠性。未来研究应聚焦于建立SCF的标准化折点、拓展罕见菌种的检测谱，并开展多中心验证以评估区域差异。本研究推荐将NMIC-413试剂盒用于CRE与CRPA分离株的抗菌药物敏感性试验，作为肉汤微量稀释法的实用替代方案。