Evaluation of the RESIST-4 O.K.N.V immunochromatographic lateral flow assay for the rapid detection of OXA-48, KPC, NDM and VIM carbapenemases from cultured isolates. Issue 5 (1st July 2019)

• Record Type: Journal Article
• Authors: MacDonald, James Wesley; Chibabhai, Vindana
• Is Part Of: Access microbiology. Volume 1:Issue 5(2019)
• Publication Date: 2019-07-01
• Subjects: carbapenemases -- RESIST-4 O.K.N.V -- OXA-48 -- KPC -- NDM -- VIM; Microbiology -- Periodicals; 579
• DOI: 10.1099/acmi.0.000031
• Languages: English
• ISSNs: 2516-8290

Abstract

Abstract : Purpose This study aimed to evaluate the performance of the RESIST-4 O.K.N.V immunochromatographic lateral flow assay for the detection of OXA-48, KPC, NDM and VIM carbapenemases in 100 clinical Enterobacteriaceae isolates using solid culture media. Methodology In total, 100 clinical Enterobacteriaceae isolates with characterized β -lactamase enzymes (OXA-48 n =46, KPC n =4, NDM n =43 and VIM n =10) were evaluated using the RESIST-4 O.K.N.V assay. The assay was also evaluated using carbapenem-sensitive control strains and confirmed non-carbapenemase-producing Enterobacteriaceae clinical isolates resistant to carbapenems. Inter-rater agreement of the test was evaluated by four different users who tested 11 randomly selected isolates daily over 3 days. Results Overall accuracy of the assay was 99.5 %. For the detection of KPC, OXA-48 and its variants and VIM the assay correctly identified 100 % of the isolates when compared to PCR. Initial performance for NDM detection was sensitivity=95.3 %, specificity=100 %. Two PCR positive Providencia rettgeri isolates rendered false negative results on the assay. Retesting from a carbapenem zone of inhibition rendered a positive result for both isolates increasing the sensitivity to 100 %. No false positive results or cross reactions were detected. Conclusion The RESIST-4 O.K.N.V is reliable, sensitive and specific for the detection of OXA-48, KPC, NDM and VIM carbapenemases. Further evaluation on improving NDM detection in organisms from the Proteeae tribe is warranted to determine optimal test conditions.