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Carbapenemase detection by NG-Test CARBA 5—a rapid immunochromatographic assay in carbapenem-resistant Enterobacterales diagnosis

BACKGROUND: The global spread of carbapenem-resistant Enterobacterales (CRE) represents a serious public health concern as these organisms are associated with limited treatment options, high mortality rate and rapid transmissibility. The identification of carbapenemase remains a challenge in microbi...

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Detalles Bibliográficos
Autores principales: Zhu, Ying, Jia, Peiyao, Li, Xue, Wang, Tong, Zhang, Jingjia, Zhang, Ge, Duan, Simeng, Kang, Wei, Xu, Yingchun, Yang, Qiwen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: AME Publishing Company 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8246204/
https://www.ncbi.nlm.nih.gov/pubmed/34268382
http://dx.doi.org/10.21037/atm-20-8216
Descripción
Sumario:BACKGROUND: The global spread of carbapenem-resistant Enterobacterales (CRE) represents a serious public health concern as these organisms are associated with limited treatment options, high mortality rate and rapid transmissibility. The identification of carbapenemase remains a challenge in microbiological laboratories as no single method is perfect when considering cost, carbapenemase coverage, accuracy, handling complexity and TATs together. METHODS: NG-Test CARBA 5 assay and modified carbapenem inactivation method in conjunction with EDTA carbapenem inactivation method (mCIM/eCIM) were challenged with a collection of 299 molecularly characterized CRE isolates in China in order to evaluate the performance in detecting five major carbapenemases (bla(KPC), bla(NDM), bla(VIM), bla(IMP), and bla(OXA-48)) among Enterobacterales. RESULTS: NG-Test CARBA 5 detected all KPC-, NDM-, VIM- and OXA-48-producing isolates perfectly with a weak false-positive signal for NDM in an IMP-4 producer, which makes the specificity for NDM decreases to 99.6%. The overall specificity/sensitivity were 99.9%/100% for NG-Test CARBA 5. mCIM/eCIM achieved high specificity of 100%/100% and sensitivity of 99.6%/97.4%, with one S. marcescens isolate harboring VIM-2 undetected. CONCLUSIONS: Both NG-Test CARBA 5 and mCIM/eCIM showed excellent results in the tested carbapenemase (bla(KPC), bla(NDM), bla(VIM), bla(IMP), and bla(OXA-48)) detection compared with molecular genotypic test. As every assay has its own limitations, suitable methods should be combined for the establishment of the CRE diagnostic pathways.