已发表论文

用于快速检测KPC和NDM碳青霉烯酶的双重侧向流免疫层析法的开发与评价

 

Authors Zhang X, Zhang J, Shen MJ, An WH, Chen ZQ, Xue J 

Received 30 November 2025

Accepted for publication 30 January 2026

Published 6 February 2026 Volume 2026:19 581873

DOI https://doi.org/10.2147/IDR.S581873

Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr Hazrat Bilal

Xian Zhang,1 Jie Zhang,2 Mei-Jing Shen,3 Wen-Hong An,1 Ze-Qiong Chen,1 Jian Xue2 

1Department of Hospital Infection, The Third Affiliated Hospital of Zunyi Medical University, The First People’s Hospital of Zunyi, Zunyi, Guizhou, 563002, People’s Republic of China; 2Department of Health Management, Zunyi Medical and Pharmaceutical College, Zunyi, Guizhou, 563006, People’s Republic of China; 3Department of Clinical Laboratory, The Third Affiliated Hospital of Zunyi Medical University, The First People’s Hospital of Zunyi, Zunyi, Guizhou, 563002, People’s Republic of China

Correspondence: Jian Xue, Department of Health Management, Zunyi Medical and Pharmaceutical College, Pingan Road, Zunyi, Guizhou, 563006, People’s Republic of China, Email xuejian912@163.com

Background: Carbapenem-resistant Enterobacterales represent a critical global health challenge, with KPC and NDM being the most prevalent carbapenemase families. Rapid and reliable detection tools are essential for guiding infection control and antimicrobial stewardship, particularly in resource-limited settings.
Methods: A lateral flow immunoassay (LFIA) strip was developed for simultaneous detection of KPC and NDM carbapenemases. Monoclonal antibody pairs were screened and assay parameters were optimized to improve analytical performance. Analytical evaluation was performed using recombinant proteins. Clinical evaluation was conducted using 12 non-duplicate clinical Klebsiella pneumoniae (K. pneumoniae) isolates, with blaKPC/blaNDM confirmed by PCR and whole-genome sequencing (WGS).
Results: The LFIA achieved limits of detection of 0.5 ng/mL for KPC and 0.1 ng/mL for NDM using recombinant proteins. No cross-reactivity was observed with other carbapenemases (OXA-48, VIM, IMP). In the clinical K. pneumoniae set, LFIA results showed 100% concordance with the PCR/WGS reference. Test results were visually interpretable within 15 minutes without specialized instrumentation.
Conclusion: This duplex LFIA provides rapid, instrument-free visual screening for KPC and NDM carbapenemases in cultured isolates, supporting routine laboratory screening and workflow decisions. Larger multi-center studies across diverse Enterobacterales species and carbapenemase variants will further define its broader clinical performance.

Keywords: lateral flow immunoassay, KPC, NDM, carbapenem-resistant Enterobacterales