Evaluation of the CRE and ESBL ELITe MGB® kits for the accurate detection of carbapenemase- or CTX-M–producing bacteria

As carbapenemase-producing Enterobacteriaceae (CPE) and extended-spectrum β-lactamase–producing Enterobacteriaceae (ESBL-E) are becoming a major public health issue, there is an urgent need for accurate and fast diagnostic tests. The ELITe InGenius is a fully automated sample-to-result system design...

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Bibliographic Details
Published in:Diagnostic microbiology and infectious disease 2018-09, Vol.92 (1), p.1-7
Main Authors: Girlich, Delphine, Bernabeu, Sandrine, Fortineau, Nicolas, Dortet, Laurent, Naas, Thierry
Format: Article
Language:English
Subjects:
Bacterial Proteins - genetics
Bacteriological Techniques - methods
beta-Lactamases - genetics
Carbapenem-Resistant Enterobacteriaceae - genetics
Carbapenemase
Confirmation
Diagnostic Tests, Routine - methods
Enterobacteriaceae Infections - genetics
Humans
Microbial Sensitivity Tests - methods
Multiplex PCR
Prospective Studies
Real-time detection
Real-Time Polymerase Chain Reaction - methods
Screening
Sensitivity and Specificity
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Summary:As carbapenemase-producing Enterobacteriaceae (CPE) and extended-spectrum β-lactamase–producing Enterobacteriaceae (ESBL-E) are becoming a major public health issue, there is an urgent need for accurate and fast diagnostic tests. The ELITe InGenius is a fully automated sample-to-result system designed for the extraction and detection by multiplex real-time polymerase chain reaction of carbapenemases KPC, NDM, VIM, IMP, and OXA-48–like variants and CTX-M group 1 and 9-producers from diverse sample matrices such as colonies, positive blood cultures, and rectal swabs. CRE and ESBL ELITe MGB® kits were evaluated on 153 cultured colonies of enterobacterial isolates with characterized β-lactamase content, on 30 spiked blood cultures, and the CRE kit was also evaluated on 53 clinical rectal swabs collected prospectively during a 3-month period and 10 spiked rectal swabs. CRE ELITe MGB® kit’s performances reached 100% sensitivity and 100% specificity, while for the ESBL ELITe kit, 100% sensitivity and 96.6% specificity were observed, with a sample to result of less than 3 h and a total percentage of agreement with expected results of 99.6% (255/256). [Display omitted] •CRE and ESBL ELITe MGB® kits for the detection of carbapenemase and ESBL genes.•Detection of KPC, NDM, VIM, IMP, and OXA-48- and CTX-M group 1 and 9 producers.•Samples (colonies, positive blood cultures, and rectal swabs) to result in less than 3 h.•CRE ELITe MGB® kit reached 100% sensitivity and 100% specificity.•ESBL ELITe MGB® kit reached 100% sensitivity and 96.6% specificity.•Total percentage of agreement with expected results: 99.6% (255/256).
ISSN:0732-8893
1879-0070
DOI:10.1016/j.diagmicrobio.2018.02.001