A prospective study on the evaluation of a novel immunochromatographic card for the rapid detection of five carbapenemase enzymes in metallo-beta-lactamase producers

一项前瞻性研究旨在评估一种新型免疫层析卡在快速检测金属β-内酰胺酶产生菌中五种碳青霉烯酶方面的应用价值。

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Abstract

Objective. To evaluate the performance of a novel immunochromatographic (IC) 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 (AES). Methods. Clinically isolated 100 non-duplicates of multidrug-resistant Gram-negative bacilli expressing MBL production were tested using the novel IC card, real-time PCR and the Vitek-2 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 min versus 5-7 h for PCR and 18-22 h 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. Considering the limited sensitivity for the IMP and VIM genes, this warrants confirmatory testing by PCR. Further evaluation is needed to assess its role as a screening or confirmatory test, especially during nosocomial outbreaks.

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