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已发表论文
环介导等温扩增（LAMP）技术用于快速灵敏检测耐碳青霉烯肠杆菌科细菌（CRE）中的碳青霉烯酶基因：一项诊断验证研究
Received 3 September 2025
Accepted for publication 1 December 2025
Published 16 December 2025 Volume 2025:18 Pages 6647—6654
DOI https://doi.org/10.2147/IDR.S559992
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Hazrat Bilal
Tiantian Gou, Yingfan Liang, Ling Li
Department of Clinical Laboratory, 363 Hospital, Sichuan, People’s Republic of China
Correspondence: Tiantian Gou, Department of Clinical Laboratory, 363 Hospital, Sichuan, People’s Republic of China, Email a362721198@126.com
Objective: To evaluate the clinical utility of loop-mediated isothermal amplification (LAMP) for detecting carbapenemase genes in carbapenem-resistant Enterobacteriaceae (CRE).
Methods: From January 2023 to December 2024, 112 clinical CRE isolates were collected, including 104 carbapenem-resistant Klebsiella pneumoniae (CR-KP), 7 Escherichia coli (CR-EC), and 1 Klebsiella oxytoca (CR-KO). These isolates were obtained primarily from sputum (n=65), urine (n=29), and bronchoalveolar lavage fluid (n=9). The isolates were predominantly isolated from neurosurgery (38.39%), intensive care unit (21.42%), and respiratory critical care medicine (15.18%). Carbapenemase genes were detected in parallel using both sequencing (reference standard) and LAMP methods under blinded conditions. Statistical analysis included cross-tabulation and Cohen’s kappa coefficient for agreement assessment.
Results: Among the 112 CRE isolates, 96.43% (108/112) carried carbapenemase resistance genes. KPC variants predominated (89/108, 82.4%), including blaKPC-2 (n=87) and blaKPC-33 (n=2). NDM variants were detected in 29 isolates (26.9%), comprising blaNDM-1 (n=14) and blaNDM-5 (n=15). OXA-48 was identified in 3 isolates (2.8%). Compared with sequencing, LAMP demonstrated perfect sensitivity (100%) for all three gene types, with specificities of 91.30% (KPC), 96.38% (NDM), and 100% (OXA-48). However, the performance data for OXA-48 should be considered preliminary due to the low number of positive isolates (n=3).The kappa values indicated excellent agreement: 0.943 (KPC), 0.932 (NDM), and 1.000 (OXA-48).
Conclusion: LAMP technology shows high diagnostic accuracy for detecting major carbapenemase genes particularly KPC and NDM in CRE isolates, offering a reliable tool for guiding appropriate antibiotic therapy. Its operational simplicity and cost-effectiveness make it particularly suitable for implementation in primary healthcare settings.
Keywords: carbapenem-resistant Enterobacteriaceae, CRE, loop-mediated isothermal amplification, LAMP, carbapenemase genes, rapid diagnostics
Department of Clinical Laboratory, 363 Hospital, Sichuan, People’s Republic of China
Correspondence: Tiantian Gou, Department of Clinical Laboratory, 363 Hospital, Sichuan, People’s Republic of China, Email a362721198@126.com
Objective: To evaluate the clinical utility of loop-mediated isothermal amplification (LAMP) for detecting carbapenemase genes in carbapenem-resistant Enterobacteriaceae (CRE).
Methods: From January 2023 to December 2024, 112 clinical CRE isolates were collected, including 104 carbapenem-resistant Klebsiella pneumoniae (CR-KP), 7 Escherichia coli (CR-EC), and 1 Klebsiella oxytoca (CR-KO). These isolates were obtained primarily from sputum (n=65), urine (n=29), and bronchoalveolar lavage fluid (n=9). The isolates were predominantly isolated from neurosurgery (38.39%), intensive care unit (21.42%), and respiratory critical care medicine (15.18%). Carbapenemase genes were detected in parallel using both sequencing (reference standard) and LAMP methods under blinded conditions. Statistical analysis included cross-tabulation and Cohen’s kappa coefficient for agreement assessment.
Results: Among the 112 CRE isolates, 96.43% (108/112) carried carbapenemase resistance genes. KPC variants predominated (89/108, 82.4%), including blaKPC-2 (n=87) and blaKPC-33 (n=2). NDM variants were detected in 29 isolates (26.9%), comprising blaNDM-1 (n=14) and blaNDM-5 (n=15). OXA-48 was identified in 3 isolates (2.8%). Compared with sequencing, LAMP demonstrated perfect sensitivity (100%) for all three gene types, with specificities of 91.30% (KPC), 96.38% (NDM), and 100% (OXA-48). However, the performance data for OXA-48 should be considered preliminary due to the low number of positive isolates (n=3).The kappa values indicated excellent agreement: 0.943 (KPC), 0.932 (NDM), and 1.000 (OXA-48).
Conclusion: LAMP technology shows high diagnostic accuracy for detecting major carbapenemase genes particularly KPC and NDM in CRE isolates, offering a reliable tool for guiding appropriate antibiotic therapy. Its operational simplicity and cost-effectiveness make it particularly suitable for implementation in primary healthcare settings.
Keywords: carbapenem-resistant Enterobacteriaceae, CRE, loop-mediated isothermal amplification, LAMP, carbapenemase genes, rapid diagnostics