Comparison of carbapenem resistance genes in Enterobacterales detected by the Biofire film Array in different panels with the rapid Lateral Flow K.N.I.V.O test | ||||
| Microbes and Infectious Diseases | ||||
| Articles in Press, Accepted Manuscript, Available Online from 03 July 2025 | ||||
| Document Type: Original Article | ||||
| DOI: 10.21608/mid.2025.390527.2849 | ||||
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| Authors | ||||
Noha Mohamed Hasanen Gaballah1; Maha M Gafaar2; Sabrin Mohamed Mohamed Elkashef   3; Marwa Mohamed Fathy Elswify1; Sara Essam2
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| 1Department of Clinical Pathology, National Cancer Institute, Cairo University, Cairo, Egypt | ||||
| 2Department of Clinical and Chemical Pathology, Faculty of Medicine, Cairo University, Cairo, Egypt | ||||
| 3Medical Microbiology and Immunology, Faculty of Medicine, Cairo University, Cairo, Egypt | ||||
| Abstract | ||||
| Background: Antimicrobial resistance (AMR) poses a significant global health threat, emphasizing the need for rapid and accurate diagnostic tools. The FDA-approved BioFire® FilmArray® system uses multiplex PCR to swiftly identify pathogens and resistance genes. Alternatively, Lateral Flow Immunoassays (LFAs) offer a faster and cost-effective means for detecting key AMR enzymes. Traditional culture methods, however, are slower and less sensitive, potentially delaying optimal treatment. This study aimed to evaluate the performance of the K.N.I.V.O. K-Set lateral flow assay, which detects five major carbapenemases (bla_KPC, bla_NDM, bla_OXA-48, bla_VIM, bla_IMP), in comparison to the BioFire® FilmArray® platform. Methods: A total of 60 clinical specimens were analyzed using conventional culture method, BioFire Film Array and lateral flow assay K.N.I.V.O k set test. Results: The most frequently detected organisms by BioFire® were Klebsiella pneumoniae (40/42; 95.2%) and Acinetobacter baumannii complex (26/42; 61.9%). In contrast, culture identified K. pneumoniae in 37/42 cases (88.1%). The most frequently detected resistance genes by BioFire® were CTX-M (76.2%), NDM (73.8%), and OXA-48 (47.6%). The lateral flow assay most frequently detected NDM (78.6%). The K.N.I.V.O. assay demonstrated 90.3% overall agreement with BioFire®, with a positive percent agreement (PPA) of 81.5% and negative percent agreement (NPA) of 94.2%. Conclusion: The K.N.I.V.O. lateral flow assay is an effective, rapid tool for detecting the five main carbapenemases, showing strong concordance with the BioFire® system. While lateral flow offers a practical point-of-care option for early resistance detection, BioFire® provides a more comprehensive profile of both pathogens and resistance mechanisms. | ||||
| Keywords | ||||
| CRE; lateral flow assay; Carbapenemases; BioFire Film Array | ||||
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