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J Antimicrob Chemother. 2016 Jul;71(7):1834-40. doi: 10.1093/jac/dkw058. Epub 2016 Mar 10.

Prospective evaluation of the OXA-48 K-SeT assay, an immunochromatographic test for the rapid detection of OXA-48-type carbapenemases.

Author information

1
Associated French National Reference Center for Antibiotic Resistance, Le Kremlin-Bicêtre, France Research Unit EA7361 'Structure, Dynamic, Function and Expression of Broad Spectrum β-Lactamases', Faculty of Medicine, University Paris-Sud, Le Kremlin-Bicêtre, France Department of Bacteriology-Parasitology-Hygiene, Bicêtre Hospital, Assistance Publique-Hôpitaux de Paris, Le Kremlin-Bicêtre, France Joint Research Unit EERA 'Evolution and Ecology of Resistance to Antibiotics', Institut Pasteur-APHP-University Paris Sud, Paris, France laurent.dortet@aphp.fr.
2
Associated French National Reference Center for Antibiotic Resistance, Le Kremlin-Bicêtre, France Research Unit EA7361 'Structure, Dynamic, Function and Expression of Broad Spectrum β-Lactamases', Faculty of Medicine, University Paris-Sud, Le Kremlin-Bicêtre, France Department of Bacteriology-Parasitology-Hygiene, Bicêtre Hospital, Assistance Publique-Hôpitaux de Paris, Le Kremlin-Bicêtre, France Joint Research Unit EERA 'Evolution and Ecology of Resistance to Antibiotics', Institut Pasteur-APHP-University Paris Sud, Paris, France.
3
Department of Bacteriology-Parasitology-Hygiene, Bicêtre Hospital, Assistance Publique-Hôpitaux de Paris, Le Kremlin-Bicêtre, France.

Abstract

OBJECTIVES:

There is an urgent need for accurate and fast diagnostic tests to identify MDR bacteria. Here, we evaluated an immunochromatographic assay (the OXA-48 K-SeT assay) to detect OXA-48-like carbapenemase-producing Enterobacteriaceae from culture colonies.

METHODS:

One hundred and sixty-one collection isolates with characterized β-lactamase content and 185 non-duplicate consecutive clinical isolates referred to the Associated French National Reference Center between 15 February and 15 March 2015 were used to evaluate the OXA-48 K-SeT assay. Among these 346 isolates, 100 were OXA-48-like carbapenemase producers, 3 were OXA-48-like producers lacking carbapenemase activity and 243 were ESBL, AmpC, oxacillinase and/or non-OXA-48 carbapenemase producers.

RESULTS:

All 100 OXA-48-like carbapenemase producers were correctly detected by the OXA-48 K-SeT assay, including OXA-48 (n = 73), OXA-181 (n = 18), OXA-162 (n = 1), OXA-204 (n = 4), OXA-232 (n = 2) and OXA-244 (n = 2) variants. The three OXA-48 variants lacking carbapenemase activity, OXA-163 (n = 2) and OXA-405 (n = 1), were not detected. All non-OXA-48 producers gave a negative result with the OXA-48 K-SeT assay. No cross-reaction was evidenced with the carbapenemases (VIM, IMP, NDM and KPC), ESBLs (TEM, SHV and CTX-M), AmpCs (CMY-2, DHA-2 and ACC-1) and oxacillinases (OXA-1, -2, -9 and -10). Overall, the sensitivity and specificity of the assay were 100% for OXA-48-like carbapenemase detection.

CONCLUSIONS:

The OXA-48 K-SeT assay was efficient, rapid and easy to implement in the routine workflow of a clinical microbiology laboratory for the confirmation of OXA-48-like carbapenemase-producing Enterobacteriaceae. It could complete the existing panel of tests available for the confirmation of OXA-48-like carbapenemases, especially in countries with high OXA-48 prevalence.

PMID:
26968882
DOI:
10.1093/jac/dkw058
[Indexed for MEDLINE]

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