Department of Microbiology and Infectious Diseases, Nara Medical University, Kashihara, Nara, Japan.
J Med Microbiol. 2022 Jun;71(6). doi: 10.1099/jmm.0.001557.
Carbapenemase-producing (CPE) pose one of the most serious antimicrobial resistance threats to public health worldwide. The outcome of CPE infection differs depending on the resistance mechanism. Therefore, rapid detection of CPE infection is essential for optimizing patient management. The carbapenem inactivation method (CIM) and modified CIM (mCIM) are standard methods for detecting CPE, but they usually require 24 h to generate results. Recently, an immunochromatographic assay, NG-Test CARBA 5, has become commercially available. It detects the five most common carbapenemase producers (KPC, IMP, NDM, VIM, and OXA-48) rapidly and accurately. We aimed to evaluate the diagnostic accuracy of NG-Test CARBA 5 for detecting carbapenemase-producing Gram-negative bacilli (CPGNB). We used 116 carbapenemase-producing strains and 48 non-carbapenemase-producing strains. Of the 116 carbapenemase-producing strains, 107 harboured genes for at least one of the five most common carbapenemases, KPC, IMP, NDM, VIM, and OXA-48-like. Forty-eight non-carbapenemase-producing strains, including carbapenem-resistant , harboured genes for extended-spectrum β-lactamases (CTX-M groups [=25] and SHV groups [=2]) or plasmid-mediated AmpC β-lactamases (DHA [=3], CMY-2 [=2], and CFE-1 [=1]). Antimicrobial susceptibility was tested using the agar dilution method, according to the Clinical and Laboratory Standards Institute guidelines. Of the 116 carbapenemase-producing strains, 79 were resistant to at least meropenem or imipenem. The sensitivity and specificity of the NG-Test CARBA 5 for the strains were 99.1 % (106 strains positive for 107 strains of the five most common carbapenemase producers) and 100 % (60 strains negative for other types of CPGNB [=10] and non-CPGNB strains [=48]), respectively. The carbapenemase-producing strain with a false-negative result produced IMP-66. The NG-Test CARBA 5 had high sensitivity and specificity for detecting carbapenemase-producing strains.
产碳青霉烯酶（CPE）对全球公共卫生构成了最严重的抗生素耐药性威胁之一。CPE 感染的结果因耐药机制而异。因此，快速检测 CPE 感染对于优化患者管理至关重要。碳青霉烯失活法（CIM）和改良 CIM（mCIM）是检测 CPE 的标准方法，但通常需要 24 小时才能得出结果。最近，一种免疫层析检测试剂盒 NG-Test CARBA 5 已商业化。它可以快速准确地检测五种最常见的产碳青霉烯酶菌（KPC、IMP、NDM、VIM 和 OXA-48）。我们旨在评估 NG-Test CARBA 5 检测产碳青霉烯酶革兰氏阴性菌（CPGNB）的诊断准确性。我们使用了 116 株产碳青霉烯酶菌株和 48 株非产碳青霉烯酶菌株。在 116 株产碳青霉烯酶菌株中，有 107 株至少携带了五种最常见的碳青霉烯酶（KPC、IMP、NDM、VIM 和 OXA-48 样）之一的基因。48 株非产碳青霉烯酶菌株，包括耐碳青霉烯的菌株，携带了扩展谱β-内酰胺酶（CTX-M 组[=25]和 SHV 组[=2]）或质粒介导的 AmpC β-内酰胺酶（DHA [=3]、CMY-2 [=2]和 CFE-1 [=1]）的基因。根据临床和实验室标准协会指南，使用琼脂稀释法测试了抗菌药物敏感性。在 116 株产碳青霉烯酶菌株中，有 79 株对至少美罗培南或亚胺培南耐药。NG-Test CARBA 5 对这 107 株产五种最常见碳青霉烯酶菌的菌株的敏感性和特异性分别为 99.1%（106 株阳性，107 株阳性）和 100%（60 株阴性，10 株为其他类型的 CPGNB[=10]和非 CPGNB 菌株[=48]）。产碳青霉烯酶菌株的假阴性结果产生了 IMP-66。NG-Test CARBA 5 对产碳青霉烯酶菌株具有较高的敏感性和特异性。
