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已发表论文
在中国开发并评估一种用于快速检测产碳青霉烯类革兰氏阴性菌的手工侧向流动免疫层析法
Authors Zhang CY, Ji J, Chen XZ, Wang WX, Chen W , Cao XL
Received 14 July 2025
Accepted for publication 15 October 2025
Published 30 October 2025 Volume 2025:18 Pages 5643—5652
DOI https://doi.org/10.2147/IDR.S543137
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Sandip Patil
Cai-Yun Zhang,1,* Jun Ji,2,* Xiu-Zhen Chen,3,4 Wei-Xiao Wang,3,4 Wei Chen,3,4 Xiao-Li Cao2
1The key Laboratory of Hepatology of Nanjing, the Second Hospital of Nanjing, Affiliated to Nanjing University of Chinese Medicine, Nanjing, Jiangsu, 210003, People’s Republic of China; 2Department of Clinical Laboratory, Nanjing Drum Tower Hospital, Affiliated to Nanjing University, Nanjing, Jiangsu, 210008, People’s Republic of China; 3Department of Tuberculosis, the Second Hospital of Nanjing, Affiliated to Nanjing University of Chinese Medicine, Nanjing, Jiangsu, 210003, People’s Republic of China; 4Clinical Research Center, the Second Hospital of Nanjing, Affiliated to Nanjing University of Chinese Medicine, Nanjing, Jiangsu, 210003, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Wei Chen, Email njyy039@njucm.edu.cn Xiao-Li Cao, Email cao-xiao-li@163.com
Background: The global dissemination of carbapenemase-producing organisms (CPOs) poses a critical public health threat. Rapid, cost-effective diagnostic tools are urgently needed to guide antimicrobial therapy and mitigate resistance spread.
Objective: This study aimed to develop and evaluate a lateral flow immunoassay (LFIA)-based workflow for the rapid detection of carbapenemases (KPC, IMP, NDM, VIM, and OXA-48) in clinical settings.
Materials and Methods: The LFIA strips targeting carbapenemases were handmade in-house using monoclonal antibodies specific to five prevalent subtypes: KPC, IMP, NDM, VIM, and OXA-48. Performance was validated using 26 characterized carbapenemase-producing Enterobacterales (CPE) strains (10 KPC, 5 IMP, 7 NDM, 1 VIM, and 3 OXA-48 producers) and 105 clinical isolates. Among them, strains positive for carbapenemase by LFIA were further confirmed by Next-generation sequencing (NGS) and PCR, and their carbapenem susceptibility was determined by the Vitek2 Antibiotics Susceptibility Test (AST). Diagnostic metrics were further assessed through limit of detection (LoD), cross-reactivity, and interference studies. The overall workflow for the development and evaluation of the LFIA is presented in Figure 1.
Results: The LFIA demonstrated 100% sensitivity in detecting all 26 CPE strains. Among 105 clinical isolates, 44 were identified as CPO strains, with strong concordance to PCR/NGS results (discrepancies in 8 isolates observed between PCR and NGS). The assay exhibited high sensitivity (100%), specificity (100%), positive predictive value (PPV, 93.2%), negative predictive value (NPV, 100%), and accuracy (97.1%). The LoD for each carbapenemase type was established. No cross-reactivity with non-target bacteria or interference from clinical substances was observed. The workflow achieved results in 15 minutes at a lower cost than conventional methods.
Conclusion: This LFIA-based workflow provides a rapid, reliable, and cost-effective solution for detecting CPOs, particularly for critically ill patients or in resource-limited settings. Its implementation could enhance therapeutic decision-making and antimicrobial stewardship.
Keywords: carbapenemase-producing organisms, lateral flow immunoassay, carbapenem-resistance, rapid detection, cost-effective workflow
1The key Laboratory of Hepatology of Nanjing, the Second Hospital of Nanjing, Affiliated to Nanjing University of Chinese Medicine, Nanjing, Jiangsu, 210003, People’s Republic of China; 2Department of Clinical Laboratory, Nanjing Drum Tower Hospital, Affiliated to Nanjing University, Nanjing, Jiangsu, 210008, People’s Republic of China; 3Department of Tuberculosis, the Second Hospital of Nanjing, Affiliated to Nanjing University of Chinese Medicine, Nanjing, Jiangsu, 210003, People’s Republic of China; 4Clinical Research Center, the Second Hospital of Nanjing, Affiliated to Nanjing University of Chinese Medicine, Nanjing, Jiangsu, 210003, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Wei Chen, Email njyy039@njucm.edu.cn Xiao-Li Cao, Email cao-xiao-li@163.com
Background: The global dissemination of carbapenemase-producing organisms (CPOs) poses a critical public health threat. Rapid, cost-effective diagnostic tools are urgently needed to guide antimicrobial therapy and mitigate resistance spread.
Objective: This study aimed to develop and evaluate a lateral flow immunoassay (LFIA)-based workflow for the rapid detection of carbapenemases (KPC, IMP, NDM, VIM, and OXA-48) in clinical settings.
Materials and Methods: The LFIA strips targeting carbapenemases were handmade in-house using monoclonal antibodies specific to five prevalent subtypes: KPC, IMP, NDM, VIM, and OXA-48. Performance was validated using 26 characterized carbapenemase-producing Enterobacterales (CPE) strains (10 KPC, 5 IMP, 7 NDM, 1 VIM, and 3 OXA-48 producers) and 105 clinical isolates. Among them, strains positive for carbapenemase by LFIA were further confirmed by Next-generation sequencing (NGS) and PCR, and their carbapenem susceptibility was determined by the Vitek2 Antibiotics Susceptibility Test (AST). Diagnostic metrics were further assessed through limit of detection (LoD), cross-reactivity, and interference studies. The overall workflow for the development and evaluation of the LFIA is presented in Figure 1.
Results: The LFIA demonstrated 100% sensitivity in detecting all 26 CPE strains. Among 105 clinical isolates, 44 were identified as CPO strains, with strong concordance to PCR/NGS results (discrepancies in 8 isolates observed between PCR and NGS). The assay exhibited high sensitivity (100%), specificity (100%), positive predictive value (PPV, 93.2%), negative predictive value (NPV, 100%), and accuracy (97.1%). The LoD for each carbapenemase type was established. No cross-reactivity with non-target bacteria or interference from clinical substances was observed. The workflow achieved results in 15 minutes at a lower cost than conventional methods.
Conclusion: This LFIA-based workflow provides a rapid, reliable, and cost-effective solution for detecting CPOs, particularly for critically ill patients or in resource-limited settings. Its implementation could enhance therapeutic decision-making and antimicrobial stewardship.
Keywords: carbapenemase-producing organisms, lateral flow immunoassay, carbapenem-resistance, rapid detection, cost-effective workflow