ArticleInfection and drug resistance2025
Development and Evaluation of a Handmade Lateral Flow Immunoassay for the Rapid Detection of Carbapenem-producing Gram-Negative Bacteria in China.
Article in Infection and drug resistance, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
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 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.
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