Evaluation of the RESIST-4 K-SeT assay, a multiplex immunochromatographic assay for the rapid detection of OXA-48-like, KPC, VIM and NDM carbapenemases

Abstract

Objectives: Accurate and fast identification of carbapenemase producers is essential for optimal patient management. Here, a new lateral flow immunochromatographic RESIST-4 K-SeT assay was assessed for the detection of carbapenemases in Enterobacteriaceae and non-fermenters.

Methods: The RESIST-4 K-SeT assay targets OXA-48-like, KPC, VIM and NDM, but not IMP carbapenemases. The assay was first evaluated using a collection of isolates with well-characterized resistance mechanisms to β-lactams (n = 134) and against an international external quality assessment carbapenemase panel (n = 8). The assay was then challenged prospectively using 345 consecutive, non-duplicate isolates including 279 Enterobacteriaceae and 66 non-fermenters (mostly Pseudomonas spp.) that were sent to the Belgian National Reference Centre for identification of the mechanisms related to carbapenem resistance.

Results: Globally, for the collection of retrospective and prospective clinical isolates (n = 479), the assay showed a sensitivity ranging from 99% for the detection of VIM to 100% for the detection of OXA-48-like, KPC and NDM carbapenemase-producing strains. The specificity was 100% for each carbapenemase and a perfect match in results was observed for the external quality assessment for the carbapenemases targeted by the assay.

Conclusions: The RESIST-4 K-SeT assay is a valuable alternative for detection and identification of carbapenemases from culture isolates compared with the more costly molecular assays, which may also further require skilled staff and dedicated facilities.