1887

Abstract

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 isolates using solid culture media.

In total, 100 clinical isolates with characterized -lactamase enzymes (OXA-48 =46, KPC =4, NDM =43 and VIM =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 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.

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 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.

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.

Keyword(s): carbapenemases , KPC , NDM , OXA-48 , RESIST-4 O.K.N.V and VIM
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2019-07-01
2019-10-22
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References

  1. Cohen Stuart J, Leverstein-Van Hall MA. Guideline for phenotypic screening and confirmation of carbapenemases in Enterobacteriaceae. Int J Antimicrob Agents 2010;36:205–210 [CrossRef]
    [Google Scholar]
  2. Glupczynski Y, Jousset A, Evrard S, Bonnin RA, Huang TD et al. 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;72:1955–1960 [CrossRef]
    [Google Scholar]
  3. Doyle D, Peirano G, Lascols C, Lloyd T, Church DL et al. Laboratory detection of Enterobacteriaceae that produce carbapenemases. J Clin Microbiol 2012;50:3877–3880 [CrossRef]
    [Google Scholar]
  4. Lutgring JD, Limbago BM. The problem of carbapenemase-producing-carbapenem-resistant-Enterobacteriaceae detection. J Clin Microbiol 2016;54:529–534 [CrossRef]
    [Google Scholar]
  5. Logan LK, Weinstein RA. The epidemiology of carbapenem-resistant Enterobacteriaceae: the impact and evolution of a global menace. J Infect Dis 2017;215:S28–S36 [CrossRef]
    [Google Scholar]
  6. van Duin D, Doi Y. The global epidemiology of carbapenemase-producing Enterobacteriaceae. Virulence 2017;8:460–469 [CrossRef]
    [Google Scholar]
  7. Nordmann P, Poirel L. The difficult-to-control spread of carbapenemase producers among Enterobacteriaceae worldwide. Clin Microbiol Infect 2014;20:821–830 [CrossRef]
    [Google Scholar]
  8. Thomas TS, Duse AG. Epidemiology of carbapenem-resistant Enterobacteriaceae (CRE) and comparison of the phenotypic versus genotypic screening tests for the detection of carbapenemases at a tertiary level, academic hospital in Johannesburg, South Africa. South Afr J Infect Dis 2018;29:1–7 [CrossRef]
    [Google Scholar]
  9. Wareham DW, Shah R, Betts JW, Phee LM, Momin M. Evaluation of an Immunochromatographic Lateral Flow Assay (OXA-48 K -SeT) for Rapid Detection of OXA-48-Like Carbapenemases in Enterobacteriaceae. J Clin Microbiol 2016;54:471–473 [CrossRef]
    [Google Scholar]
  10. Rodríguez-Baño J, Gutiérrez-Gutiérrez B, Machuca I, Pascual A. Treatment of infections caused by extended-spectrum-beta-lactamase-, AmpC-, and carbapenemase-producing Enterobacteriaceae. Clin Microbiol Rev 2018;31:e00079–17
    [Google Scholar]
  11. Wareham DW, Phee LM, Abdul Momin MHF. Direct detection of carbapenem resistance determinants in clinical specimens using immunochromatographic lateral flow devices. J Antimicrob Chemother 2018
    [Google Scholar]
  12. M100Ed28 Performance Standards for Antimicrobial Susceptibility Testing, 28th ed. Clinical & Laboratory Standards Institute; 2018
    [Google Scholar]
  13. Chibabhai V, Nana T, Bosman N, Thomas T, Lowman W. Were all carbapenemases created equal? Treatment of NDM-producing extensively drug-resistant Enterobacteriaceae: a case report and literature review. Infection 2018;46:1–13 [CrossRef]
    [Google Scholar]
  14. Tamma PD, Goodman KE, Harris AD, Tekle T, Roberts A et al. Comparing the outcomes of patients with carbapenemase-producing and non-carbapenemase-producing carbapenem-resistant Enterobacteriaceae Bacteremia. Clin Infect Dis 2017;64:257–264 [CrossRef]
    [Google Scholar]
  15. Wareham DW, Abdul Momin MH. Rapid detection of carbapenemases in Enterobacteriaceae: evaluation of the Resist-3 O.K.N. (OXA-48, KPC, NDM) lateral flow multiplexed assay. J Clin Microbiol 2017;55:1223–1225 [CrossRef]
    [Google Scholar]
  16. Wu G, Zaman MH. Low-cost tools for diagnosing and monitoring HIV infection in low-resource settings. Bull World Health Organ 2012;90:914–920 [CrossRef]
    [Google Scholar]
  17. Saleh A, Göttig S, Hamprecht AG. Multiplex immunochromatographic detection of OXA-48, KPC, and NDM carbapenemases: impact of inoculum, antibiotics, and agar. J Clin Microbiol 2018;56:e00050–18 [CrossRef]
    [Google Scholar]
  18. Glupczynski Y, Evrard S, Ote I, Mertens P, Huang TD et al. Evaluation of two new commercial immunochromatographic assays for the rapid detection of OXA-48 and KPC carbapenemases from cultured bacteria. J Antimicrob Chemother 2016;71:1217–1222 [CrossRef]
    [Google Scholar]
  19. Riccobono E, Antonelli A, Pecile P, Bogaerts P, D’Andrea MM et al. Evaluation of the KPC K-SeT® immunochromatographic assay for the rapid detection of KPC carbapenemase producers from positive blood cultures. J Antimicrob Chemother 2018;73:539–540 [CrossRef]
    [Google Scholar]
  20. Sağıroğlu P, Hasdemir U, Altınkanat Gelmez G, Aksu B, Karatuna O et al. Performance of "RESIST-3 O.K.N. K-SeT" immunochromatographic assay for the detection of OXA-48 like, KPC, and NDM carbapenemases in Klebsiella pneumoniae in Turkey. Braz J Microbiol 2018;49:885–890 [CrossRef]
    [Google Scholar]
  21. Kolenda C, Benoit R, Carricajo A, Bonnet R, Dauwalder O et al. Evaluation of the new multiplex immunochromatographic O.K.N.V K-Set assay for the rapid detection of OXA-48-like, KPC, NDM and VIM carbapenemases. J Clin Microbiol 2018;01247–18
    [Google Scholar]
  22. Greissl C, Saleh A, Hamprecht A. Rapid detection of OXA-48-like, KPC, NDM, and VIM carbapenemases in Enterobacterales by a new multiplex immunochromatographic test. Eur J Clin Microbiol Infect Dis 2019;38:331–335 [CrossRef]
    [Google Scholar]
  23. Baeza LL, Pfennigwerth N, Greissl C, Göttig S, Saleh A et al. Comparison of five methods for detection of carbapenemases in Enterobacterales with proposal of a new algorithm. Clin Microbiol Infect 2019;18Mar 2019; [CrossRef]
    [Google Scholar]
  24. Glupczynski Y, Evrard S, Huang TD, Bogaerts P. 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. J Antimicrob Chemother 2019
    [Google Scholar]
  25. Perovic O, Britz E, Chetty V, Singh-Moodley A. Molecular detection of carbapenemase-producing genes in referral Enterobacteriaceae in South Africa: a short report. S Afr Med J 2016;106:975–977 [CrossRef]
    [Google Scholar]
  26. Package insert the Resist-4 O.K.N.V immunochromatographic test 2018; Gembloux, Belgium: Corris BioConcept;
  27. Leeflang MMG, Allerberger F. How to: evaluate a diagnostic test. Clin Microbiol Infect 2019;25:54–59 [CrossRef]
    [Google Scholar]
  28. EWING WH. The tribe Proteeae: its nomenclature and taxonomy. Int J Syst Evol Microbiol 1962;12:93–102 [CrossRef]
    [Google Scholar]
  29. Procop GW, Church D, Hall G, Janda WM, Koneman EW et al. Koneman’s Color Atlas and Textbook of Diagnostic Microbiolgy Philadelphia, Pa: Lippincott, Williams & Wilkins; 2017
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