Prospective evaluation of the OKN K-SeT assay, a new multiplex immunochromatographic test for the rapid detection of OXA-48-like, KPC and NDM carbapenemases

J Antimicrob Chemother. 2017 Jul 1;72(7):1955-1960. doi: 10.1093/jac/dkx089.

Abstract

Objectives: There is an urgent need for accurate and fast diagnostic tests capable of identifying carbapenemase producers. Here, we assessed the performance of a new multiplex lateral flow assay (OKN K -SeT) for the rapid detection of OXA-48-like, KPC and NDM carbapenemase-producing Enterobacteriaceae from culture colonies.

Methods: Two hundred collection isolates with characterized β-lactamase content and 183 non-duplicate consecutive isolates referred to two National Reference Centres over a 2 month period in 2016 were used to evaluate the OKN K -SeT assay.

Results: The assay correctly detected all 42 OXA-48-like-, 27 KPC- and 30 NDM-producing isolates from the collection panel, including 7 isolates that co-produced NDM and OXA-181 carbapenemases. No cross-reactivity was observed with non-targeted carbapenemases ( n = 41) or with non-carbapenemase producers ( n = 60). Prospectively, all OXA-48-like ( n = 69), KPC ( n = 9) and NDM ( n = 19) carbapenemase-producing Enterobacteriaceae isolates were correctly detected, while 11 carbapenemase producers not targeted by the assay went undetected [VIM ( n = 8) and OXA-23/OXA-58-like ( n = 3)]. Overall, the sensitivity and specificity of the assay were 100%.

Conclusions: The OKN assay is efficient, rapid and easy to implement in the workflow of a clinical microbiology laboratory for the confirmation of OXA-48, NDM and KPC carbapenemases. This test represents a powerful diagnostic tool as it enables the rapid detection of the most clinically important carbapenemases without the need for more costly and less frequently available molecular assays.

Publication types

  • Evaluation Study

MeSH terms

  • Bacterial Proteins / analysis
  • Bacterial Proteins / biosynthesis*
  • Bacterial Proteins / immunology
  • Bacteriological Techniques
  • Carbapenem-Resistant Enterobacteriaceae / enzymology
  • Carbapenem-Resistant Enterobacteriaceae / immunology
  • Carbapenem-Resistant Enterobacteriaceae / isolation & purification*
  • Carbapenem-Resistant Enterobacteriaceae / metabolism
  • Chromatography, Affinity / methods*
  • Enterobacteriaceae Infections / diagnosis*
  • Enterobacteriaceae Infections / microbiology
  • Humans
  • Microbial Sensitivity Tests
  • Prospective Studies
  • Sensitivity and Specificity
  • beta-Lactamases / analysis
  • beta-Lactamases / biosynthesis*
  • beta-Lactamases / immunology

Substances

  • Bacterial Proteins
  • beta-Lactamases
  • carbapenemase