Comparison of the NG-Test Carba 5, Colloidal Gold Immunoassay (CGI) Test, and Xpert Carba-R for the Rapid Detection of Carbapenemases in Carbapenemase-Producing Organisms

Carbapenem-resistant Enterobacterales (CRE) are increasingly recognized as an urgent public health concern. The rapid and accurate identification of carbapenemases could provide insights into antimicrobial therapy and infection control. In this study, we evaluated the efficacy of three different met...

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Main Authors: Danxia Gu, Zelin Yan, Chang Cai, Jiaping Li, Yanyan Zhang, Yuchen Wu, Jiaxing Yang, Yonglu Huang, Rong Zhang, Yongning Wu
Format: Article
Language:English
Published: MDPI AG 2023-02-01
Series:Antibiotics
Subjects:
Online Access:https://www.mdpi.com/2079-6382/12/2/300
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author Danxia Gu
Zelin Yan
Chang Cai
Jiaping Li
Yanyan Zhang
Yuchen Wu
Jiaxing Yang
Yonglu Huang
Rong Zhang
Yongning Wu
author_facet Danxia Gu
Zelin Yan
Chang Cai
Jiaping Li
Yanyan Zhang
Yuchen Wu
Jiaxing Yang
Yonglu Huang
Rong Zhang
Yongning Wu
author_sort Danxia Gu
collection DOAJ
description Carbapenem-resistant Enterobacterales (CRE) are increasingly recognized as an urgent public health concern. The rapid and accurate identification of carbapenemases could provide insights into antimicrobial therapy and infection control. In this study, we evaluated the efficacy of three different methods, including the NG-test Carba 5, colloidal gold immunoassay (CGI) test, and Xpert Carba-R assay, for the rapid detection of five carbapenemases (KPC, NDM, IMP, OXA-48, and VIM). A total of 207 Gram-negative strains collected from patients and hospital sewages were tested. The presence or absence of carbapenemase genes in the whole-genome sequences was used as the gold standard for evaluating the accuracy of the above-mentioned three methods. Among the 192 strains carrying only one carbapenemase gene, the accuracies of the NG-Test Carba 5, CGI test, and Xpert Carba-R were 96.88% (95% CI, 93.01–98.72%), 96.88% (95% CI, 93.01–98.72%), and 97.92% (95% CI, 94.41–99.33%), respectively. Xpert Carba-R was able to detect all 13 types of KPC variants, including KPC-2, KPC-3, KPC-25, KPC-33, KPC-35, KPC-51, KPC-52, KPC-71, KPC-76, KPC-77, KPC-78, KPC-93, and KPC-123, with a detection sensitivity of 100.00% (95% CI, 96.50–100.00%), a specificity of 100.00% (95% CI, 92.38–100.00%), and a κ index of 1.00. For IMP, Carba 5 was superior to the other two methods, with a sensitivity of 100% (95% CI, 71.66–100.00%), a specificity of 100% (95% CI, 97.38–100.00%), and a κ index of 1.00. For the remaining 15 strains carrying two or three kinds of carbapenemase genes, Carba 5 performed the best, which accurately identified all the target genes, followed by Xpert Carba-R (12/15, 80.00%) and the CGI test (10/15, 66.67%). Therefore, all three assays demonstrated reliable performances in carbapenemase detection, and Xpert Carba-R should be recommended for the detection of KPC variants, especially for patients at a high risk of infections caused by ceftazidime/avibactam-resistant strains. IMPORTANCE: CRE was listed as one of the top three pathogens that are in critical need of new antibiotics by the WHO. The rapid and accurate identification of carbapenemases is important for antimicrobial therapy and infection control. In recent years, new beta-lactam/beta-lactamase inhibitor combinations such as ceftazidime/avibactam (CZA) have been approved by the Food and Drug Administration (FDA) to cope with CRE challenges. CZA was effective against class A, class C, and some class D enzymes such as OXA-48-like. However, CZA-resistant KPC variants emerged at an alarming speed, which posed a new challenge for the accurate identification of KPC variants. In this study, we evaluated the performance of two lateral flow immunochromatographic assays, namely, NG-test Carba 5 and the CGI test, and the automated real-time quantitative PCR Xpert Carba-R in the rapid detection of carbapenemases. Notably, 13 types of KPC variants were enrolled in this study, which covered most KPC variants discovered in China. Carba-R was superior to NG-teat Carba 5 and the CGI test; it was able to detect all of the included KPC variants, including KPC-2, KPC-3, KPC-25, KPC-33, KPC-35, KPC-51, KPC-52, KPC-71, KPC-76, KPC-77, KPC-78, KPC-93, and KPC-123.
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spelling doaj.art-2926feb3f3b942ce95d03505fadc42292023-11-16T18:43:03ZengMDPI AGAntibiotics2079-63822023-02-0112230010.3390/antibiotics12020300Comparison of the NG-Test Carba 5, Colloidal Gold Immunoassay (CGI) Test, and Xpert Carba-R for the Rapid Detection of Carbapenemases in Carbapenemase-Producing OrganismsDanxia Gu0Zelin Yan1Chang Cai2Jiaping Li3Yanyan Zhang4Yuchen Wu5Jiaxing Yang6Yonglu Huang7Rong Zhang8Yongning Wu9Laboratory Medicine Center, Department of Clinical Laboratory, Zhejiang Provincial People’s Hospital, Affiliated People’s Hospital, Hangzhou Medical College, Hangzhou 310014, ChinaDepartment of Clinical Laboratory, Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou 310009, ChinaCollege of Animal Science and Technology, College of Veterinary Medicine, Zhejiang Agricultural and Forestry University, Hangzhou 311300, ChinaDepartment of Clinical Laboratory, Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou 310009, ChinaDepartment of Clinical Laboratory, Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou 310009, ChinaDepartment of Clinical Laboratory, Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou 310009, ChinaDepartment of Clinical Laboratory, Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou 310009, ChinaDepartment of Clinical Laboratory, Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou 310009, ChinaDepartment of Clinical Laboratory, Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou 310009, ChinaNHC Key Laboratory of Food Safety Risk Assessment, China National Center for Food Safety Risk Assessment, Research Unit of Food Safety, Chinese Academy of Medical Sciences (2019RU014), Beijing 100022, ChinaCarbapenem-resistant Enterobacterales (CRE) are increasingly recognized as an urgent public health concern. The rapid and accurate identification of carbapenemases could provide insights into antimicrobial therapy and infection control. In this study, we evaluated the efficacy of three different methods, including the NG-test Carba 5, colloidal gold immunoassay (CGI) test, and Xpert Carba-R assay, for the rapid detection of five carbapenemases (KPC, NDM, IMP, OXA-48, and VIM). A total of 207 Gram-negative strains collected from patients and hospital sewages were tested. The presence or absence of carbapenemase genes in the whole-genome sequences was used as the gold standard for evaluating the accuracy of the above-mentioned three methods. Among the 192 strains carrying only one carbapenemase gene, the accuracies of the NG-Test Carba 5, CGI test, and Xpert Carba-R were 96.88% (95% CI, 93.01–98.72%), 96.88% (95% CI, 93.01–98.72%), and 97.92% (95% CI, 94.41–99.33%), respectively. Xpert Carba-R was able to detect all 13 types of KPC variants, including KPC-2, KPC-3, KPC-25, KPC-33, KPC-35, KPC-51, KPC-52, KPC-71, KPC-76, KPC-77, KPC-78, KPC-93, and KPC-123, with a detection sensitivity of 100.00% (95% CI, 96.50–100.00%), a specificity of 100.00% (95% CI, 92.38–100.00%), and a κ index of 1.00. For IMP, Carba 5 was superior to the other two methods, with a sensitivity of 100% (95% CI, 71.66–100.00%), a specificity of 100% (95% CI, 97.38–100.00%), and a κ index of 1.00. For the remaining 15 strains carrying two or three kinds of carbapenemase genes, Carba 5 performed the best, which accurately identified all the target genes, followed by Xpert Carba-R (12/15, 80.00%) and the CGI test (10/15, 66.67%). Therefore, all three assays demonstrated reliable performances in carbapenemase detection, and Xpert Carba-R should be recommended for the detection of KPC variants, especially for patients at a high risk of infections caused by ceftazidime/avibactam-resistant strains. IMPORTANCE: CRE was listed as one of the top three pathogens that are in critical need of new antibiotics by the WHO. The rapid and accurate identification of carbapenemases is important for antimicrobial therapy and infection control. In recent years, new beta-lactam/beta-lactamase inhibitor combinations such as ceftazidime/avibactam (CZA) have been approved by the Food and Drug Administration (FDA) to cope with CRE challenges. CZA was effective against class A, class C, and some class D enzymes such as OXA-48-like. However, CZA-resistant KPC variants emerged at an alarming speed, which posed a new challenge for the accurate identification of KPC variants. In this study, we evaluated the performance of two lateral flow immunochromatographic assays, namely, NG-test Carba 5 and the CGI test, and the automated real-time quantitative PCR Xpert Carba-R in the rapid detection of carbapenemases. Notably, 13 types of KPC variants were enrolled in this study, which covered most KPC variants discovered in China. Carba-R was superior to NG-teat Carba 5 and the CGI test; it was able to detect all of the included KPC variants, including KPC-2, KPC-3, KPC-25, KPC-33, KPC-35, KPC-51, KPC-52, KPC-71, KPC-76, KPC-77, KPC-78, KPC-93, and KPC-123.https://www.mdpi.com/2079-6382/12/2/300KPC variantscarbapenemaserapid detectionNG-test Carba 5Xpert Carba-Revaluation
spellingShingle Danxia Gu
Zelin Yan
Chang Cai
Jiaping Li
Yanyan Zhang
Yuchen Wu
Jiaxing Yang
Yonglu Huang
Rong Zhang
Yongning Wu
Comparison of the NG-Test Carba 5, Colloidal Gold Immunoassay (CGI) Test, and Xpert Carba-R for the Rapid Detection of Carbapenemases in Carbapenemase-Producing Organisms
Antibiotics
KPC variants
carbapenemase
rapid detection
NG-test Carba 5
Xpert Carba-R
evaluation
title Comparison of the NG-Test Carba 5, Colloidal Gold Immunoassay (CGI) Test, and Xpert Carba-R for the Rapid Detection of Carbapenemases in Carbapenemase-Producing Organisms
title_full Comparison of the NG-Test Carba 5, Colloidal Gold Immunoassay (CGI) Test, and Xpert Carba-R for the Rapid Detection of Carbapenemases in Carbapenemase-Producing Organisms
title_fullStr Comparison of the NG-Test Carba 5, Colloidal Gold Immunoassay (CGI) Test, and Xpert Carba-R for the Rapid Detection of Carbapenemases in Carbapenemase-Producing Organisms
title_full_unstemmed Comparison of the NG-Test Carba 5, Colloidal Gold Immunoassay (CGI) Test, and Xpert Carba-R for the Rapid Detection of Carbapenemases in Carbapenemase-Producing Organisms
title_short Comparison of the NG-Test Carba 5, Colloidal Gold Immunoassay (CGI) Test, and Xpert Carba-R for the Rapid Detection of Carbapenemases in Carbapenemase-Producing Organisms
title_sort comparison of the ng test carba 5 colloidal gold immunoassay cgi test and xpert carba r for the rapid detection of carbapenemases in carbapenemase producing organisms
topic KPC variants
carbapenemase
rapid detection
NG-test Carba 5
Xpert Carba-R
evaluation
url https://www.mdpi.com/2079-6382/12/2/300
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