A prospective study on evaluation of Novel Immunochromatographic card for rapid detection of Five carbapenemases enzymes in metallobetalactamase producers.

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Abstract

Objective To evaluate the performance of a novel immunochromatographic card test (TRURAPID® O.K.N.V.I. RESIST-5) for rapid detection of five carbapenemase enzymes in metallo-beta-lactamase (MBL) producing organisms, compared to real-time PCR and an advanced expert system. Methods Isolated clinically 100 non-duplicates of multidrug-resistant Gram-negative bacilli (GNB) expressing MBL production were tested using the novel IC card, real-time PCR, and the Vitek-2 Advanced Expert System (AES). Sensitivity, specificity, and turnaround time were evaluated. Results The novel IC card showed high sensitivity for detecting NDM (93%) and KPC (91.7%) carbapenemases, but lower sensitivity for OXA-48 (60%), VIM (67%), and IMP (33%) compared to PCR. It had a rapid turnaround time of 15-20 minutes versus 5-7 hours for PCR and 18-22 hours for AES. Conclusion The novel IC card offers a rapid, cost-effective approach for detecting carbapenemases, particularly NDM and KPC, in clinical microbiology practice. It may be beneficial in resource-limited settings where these enzymes are prevalent. Further evaluation is needed to assess its role as a screening or confirmatory test, especially during nosocomial outbreaks. Data Summary New tool is being evaluated against Polymerase chain reaction for early detection of carbapenemase gene. No code or software is generated. Impact Statement This article evaluates a novel immunochromatographic card test for rapid detection of five carbapenemase enzymes in metallo-beta-lactamase producing bacteria. The Novel IC test showed high sensitivity for NDM, OXA and KPC enzymes, which is pertinent in context to Indian subcontinent. It offers a rapid 15-20 minutes turnaround time versus hours for other methods, potentially beneficial in resource-limited settings in a fight against carbapenem resistance.

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