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

Access microbiology Pub Date : 2025-09-10 eCollection Date: 2025-01-01 DOI:10.1099/acmi.0.001024.v3
Jyotsna Agarwal, Vikramjeet Singh, Avneesh Sharma, Manodeep Sen, Anupam Das
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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.

一种新型免疫层析卡快速检测金属-内酰胺酶生产者中5种碳青霉烯酶的前瞻性研究。
目标。评价一种新型免疫层析(IC)卡测试(TRURAPID®O.K.N.V.I. resistance -5)在金属β -内酰胺酶(MBL)产生生物中快速检测五种碳青霉烯酶的性能,与实时PCR和高级专家系统(AES)进行比较。方法。采用新型IC卡、实时荧光定量PCR和Vitek-2 AES检测临床分离的100株表达MBL的非重复多重耐药革兰氏阴性杆菌。评估敏感性、特异性和周转时间。结果。与PCR相比,新型IC卡对NDM(93%)和KPC(91.7%)碳青霉烯酶的检测灵敏度较高,但对OXA-48(60%)、VIM(67%)和IMP(33%)的灵敏度较低。它的周转时间为15-20 min,而PCR为5-7 h, AES为18-22 h。结论。这种新型IC卡为临床微生物学实践中检测碳青霉烯酶,特别是NDM和KPC提供了一种快速、经济的方法。在这些酶普遍存在的资源有限的环境中,它可能是有益的。考虑到IMP和VIM基因的有限敏感性,这需要通过PCR进行验证性测试。需要进一步评估其作为筛查或确诊试验的作用,特别是在医院暴发期间。
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