Prospective evaluation of the OXA-48<i>K</i>-SeT assay, an immunochromatographic test for the rapid detection of OXA-48-type carbapenemases

Dortet, Laurent; Jousset, Agnès B; Sainte-Rose, Vincent; Cuzon, Gaëlle; Naas, Thierry

doi:10.1093/jac/dkw058

Cited by 47 publications

(28 citation statements)

References 20 publications

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“…The OXA-163/48 Duo K-SeT test differentiates between subfamilies with distinct substrate profiles, such as OXA-48 and OXA-163, obviating the need for more costly and lengthy characterization with molecular amplification methods. The assay was highly sensitive and specific and detected the presence of OXA-48-producing strains within seconds to minutes, similar to results previously reported for the OXA-48 subfamily and KPC carbapenemases (7)(8)(9)(10)25). No significant difference in band intensities was observed between the different subfamilies and/or variants tested or between the bacterial species, in carbapenem MICs, or in associations of the OXA protein to other ␤-lactamases (data not shown).…”

supporting

confidence: 87%

“…The OXA-48 K-SeT test (Coris BioConcept, Belgium) relies on immunological capture of two epitopes specific to the OXA-48 variants OXA-48, OXA-181, OXA-204, OXA-232, and OXA-244 using colloidal gold nanoparticles bound to a nitrocellulose membrane within a lateral flow device (6). The reported sensitivity and specificity were both 100%, with the result obtained in less than 10 min (6)(7)(8)(9)(10). Noteworthy is that new allelic variants of OXA-48 have emerged, namely, OXA-163 and the related variants OXA-247, OXA-405, and OXA-438 (11)(12)(13)(14), which are not recognized by the OXA-48 K-SeT test (6,8,10).…”

mentioning

confidence: 96%

“…The reported sensitivity and specificity were both 100%, with the result obtained in less than 10 min (6-10). Noteworthy is that new allelic variants of OXA-48 have emerged, namely, OXA-163 and the related variants OXA-247, , which are not recognized by the OXA-48 K-SeT test (6,8,10). OXA-163, which is the only variant of this subfamily that has spread to several hospitals in Argentina and Egypt (15, 16), differs from OXA-48 by a single amino acid substitution and a four-amino-acid deletion.…”

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confidence: 99%

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Rapid Identification of OXA-48 and OXA-163 Subfamilies in Carbapenem-Resistant Gram-Negative Bacilli with a Novel Immunochromatographic Lateral Flow Assay

et al. 2016

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dWe assessed a novel immunochromatographic lateral flow assay for direct identification of OXA-48-like carbapenemases and accurate differentiation of allele variants with distinct substrate profiles (OXA-48 or OXA-163 subfamilies). The assay allowed rapid (less than 4 min) and reliable direct confirmation of OXA-163-and/or OXA-48-like enzymes (with 100% sensitivity and 100% specificity) from cultured colonies that were recovered from both solid medium and spiked blood culture bottles. The emergence and spread of Enterobacteriaceae that produce plasmids encoding class A (KPC, GES, Sme, NMC-A), B (IMP, VIM, NDM), and D (OXA-48-like) carbapenemases are worldwide public health threats. To prevent the spread of carbapenemase producers and define an appropriate empirical antimicrobial therapy, the rapid detection of carbapenemase-producing organisms has become imperative (1). One of the major concerns for controlling the spread of OXA-48-like producers is the absence of reliable phenotypical tests that might contribute to their easy recognition. This is due in part to relatively low carbapenem MICs, a lack of suitable inhibitor compounds for use in confirmatory tests, and the very low expression of carbapenemase activity which cannot be detected readily by recently developed biochemical methods (1-5). Recently, a novel means of detecting OXA-48-like enzymes via an antibody-mediated approach was developed (6). The OXA-48 K-SeT test (Coris BioConcept, Belgium) relies on immunological capture of two epitopes specific to the OXA-48 variants OXA-48, OXA-181, OXA-204, OXA-232, and OXA-244 using colloidal gold nanoparticles bound to a nitrocellulose membrane within a lateral flow device (6). The reported sensitivity and specificity were both 100%, with the result obtained in less than 10 min (6-10). Noteworthy is that new allelic variants of OXA-48 have emerged, namely, OXA-163 and the related variants OXA-247, , which are not recognized by the OXA-48 K-SeT test (6,8,10). OXA-163, which is the only variant of this subfamily that has spread to several hospitals in Argentina and Egypt (15, 16), differs from OXA-48 by a single amino acid substitution and a four-amino-acid deletion. In earlier studies, OXA-163 exhibited almost undetectable carbapenemase activity with a substrate profile that included broad-spectrum cephalosporins (11). However, recent reports indicate that this allele might produce enhanced carbapenemase activity in the presence of carbonates (13, 17), suggesting that its activity is strongly influenced by the rate of carboxylation of the active site, as observed for other carbapenem-hydrolyzing class D ␤-lactamases (18,19). Additionally, in vivo data suggested that OXA-163 might cause carbapenem treatment failures in critically ill patients (12,15,20) or favor intrapatient selection of new OXA-48 variants (12), which highlights the urgent need for efficient identification tests.Definitive confirmation of OXA-163-and/or OXA-48-like producers currently relies on molecular assays and gene sequencing for the assign...

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confidence: 87%

mentioning

confidence: 96%

mentioning

confidence: 99%

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Rapid Identification of OXA-48 and OXA-163 Subfamilies in Carbapenem-Resistant Gram-Negative Bacilli with a Novel Immunochromatographic Lateral Flow Assay

et al. 2016

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“…The simple protocol and required materials makes it promising for widespread adoption by clinical microbiology labs [van der Zwaluw 2015]. An immunochromatographic assay had perfect sensitivity (100%) and specificity (100%) at detecting OXA-48-like CPE compared to isolates possessing OXA-48-like variants lacking carbapenemase activity or Class A and B carbapenemases [Dortet 2016]. Accurate detection methods are important for developing ideal patient treatment options and surveillance of carbapenemases.…”

Section: Detectionmentioning

confidence: 99%

The rapid spread of carbapenem-resistant Enterobacteriaceae

Potter

D’Souza

Dantas

2016

Drug Resistance Updates

318

211

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Carbapenems, our one-time silver bullet for multidrug resistant bacterial infections, are now threatened by widespread dissemination of carbapenem-resistant Enterobacteriaceae (CRE). Successful expansion of Enterobacteriaceae clonal groups and frequent horizontal gene transfer of carbapenemase expressing plasmids are causing increasing carbapenem resistance. Recent advances in genetic and phenotypic detection facilitate global surveillance of CRE diversity and prevalence. In particular, whole genome sequencing enabled efficient tracking, annotation, and study of genetic elements colocalized with carbapenemase genes on chromosomes and on plasmids. Improved characterization helps detail the co-occurrence of other antibiotic resistance genes in CRE isolates and helps identify pan-drug resistance mechanisms. The novel β-lactamase inhibitor, avibactam, combined with ceftazidime or aztreonam, is a promising CRE treatment compared to current colistin or tigecycline regimens. To halt increasing CRE-associated morbidity and mortality, we must continue quality, cooperative monitoring and urgently investigate novel treatments.

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“…Although very few novel antibiotics are, or will be, available for the treatment of CPE, the most promising therapies involve combinations of a broad-spectrum ␤-lactam and novel ␤-lactamase inhibitors (e.g., ceftazidime-avibactam, imipenem-relebactam) active on class A carbapenemases and on class D (for avibactam only) but not on MBLs (6,7). During the last 3 years, several methods have been developed for the detection of CPE, including (i) tests able to detect carbapenem-hydrolyzing activity (Carba NP test and derivatives [8][9][10], matrix-assisted laser desorption ionization-time of flight [MALDI-TOF] protocols [11,12], Bogaerts-Yunus-Glupczynski [BYG] test [13], carbapenem inactivation method [CIM] test [14,15], and ␤ Carba [16]), (ii) immuno-chromatographic tests for the rapid detection of KPC, OXA-48-type, and NDM carbapenemases (17)(18)(19), (iii) combination disk diffusion assays (20), and (iv) molecular-based techniques that aim to detect the most widespread carbapenemase-encoding genes (21)(22)(23).…”

mentioning

confidence: 99%

Comparison of Two Phenotypic Algorithms To Detect Carbapenemase-Producing Enterobacteriaceae

Dortet

Bernabeu

Gonzalez

et al. 2017

Antimicrob Agents Chemother

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A novel algorithm designed for the screening of carbapenemase-producing Enterobacteriaceae (CPE), based on faropenem and temocillin disks, was compared to that of the Committee of the Antibiogram of the French Society of Microbiology (CA-SFM), which is based on ticarcillin-clavulanate, imipenem, and temocillin disks. The two algorithms presented comparable negative predictive values (98.6% versus 97.5%) for CPE screening among carbapenem-nonsusceptible Enterobacteriaceae. However, since 46.2% (n ϭ 49) of the CPE were correctly identified as OXA-48-like producers by the faropenem/temocillin-based algorithm, it significantly decreased the number of complementary tests needed (42.2% versus 62.6% with the CA-SFM algorithm).KEYWORDS OXA-48, KPC, NDM, VIM, IMP disk diffusion susceptibility testing, bacterial susceptibility testing, carbapenemase, disk diffusion C arbapenem resistance caused by carbapenemase production has been increasingly reported worldwide in Enterobacteriaceae (1, 2). In most of the cases, these carbapenemases belong to Ambler class A (mostly KPC and GES types) (3), Ambler class B or metallo-␤-lactamases (MBLs) of VIM, IMP (1, 2), and NDM types (4), or carbapenemhydrolyzing Ambler class D ␤-lactamases (CHDLs) (mostly OXA-48-like) (5). The spread of carbapenemase-producing Enterobacteriaceae (CPE) represents a serious threat for public health and requires their rapid identification to implement proper infection control measures to prevent further spread in hospitals and initiate proper treatments. Although very few novel antibiotics are, or will be, available for the treatment of CPE, the most promising therapies involve combinations of a broad-spectrum ␤-lactam and novel ␤-lactamase inhibitors (e.g., ceftazidime-avibactam, imipenem-relebactam) active on class A carbapenemases and on class D (for avibactam only) but not on MBLs (6, 7). During the last 3 years, several methods have been developed for the detection of CPE, including (i) tests able to detect carbapenem-hydrolyzing activity (Carba NP test and derivatives [8][9][10] , (iii) combination disk diffusion assays (20), and (iv) molecular-based techniques that aim to detect the most widespread carbapenemase-encoding genes (21-23).The ability to infer from routine antibiogram the presence of a carbapenemase is often complicated and requires complementary tests, leading to additional delay and cost for clinical laboratories. Accordingly, it is of importance to develop solutions (e.g., algorithms) with high sensitivities and negative predictive values (NPVs) to discriminate

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

Cited by 47 publications

References 20 publications

Rapid Identification of OXA-48 and OXA-163 Subfamilies in Carbapenem-Resistant Gram-Negative Bacilli with a Novel Immunochromatographic Lateral Flow Assay

Rapid Identification of OXA-48 and OXA-163 Subfamilies in Carbapenem-Resistant Gram-Negative Bacilli with a Novel Immunochromatographic Lateral Flow Assay

The rapid spread of carbapenem-resistant Enterobacteriaceae

Comparison of Two Phenotypic Algorithms To Detect Carbapenemase-Producing Enterobacteriaceae

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