title: Evaluation of the Rapidec Carba NP Test for Detection of Carbapenemases in Enterobacteriaceae.
abstract: This study evaluated the performance of the Rapidec Carba NP test, which was introduced recently into the market for the detection of carbapenemase production in a broad spectrum of β-lactamase-producing Enterobacteriaceae clinical isolates. In total, 252 clinical Enterobacteriaceae isolates that had been genetically characterized with respect to carbapenemase, extended-spectrum β-lactamase (ESBL), and AmpC genes were analyzed; 51/252 isolates (20.2%) were genetically confirmed to be carbapenemase producers, whereas 201/252 isolates (79.8%) were genetically negative for the presence of carbapenemase genes. The Rapidec Carba NP test was applied according to the manufacturer's instructions, and results were read after 30 and 120 min of incubation. The overall sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the Rapidec Carba NP test were 90.2%, 100%, 100%, and 97.6%, respectively, when the manufacturer's instructions were followed. Four of 5 false-negative results occurred with OXA-48-like enzymes. After an incubation time of 30 min, the sensitivity was 49%. The sensitivity increased to 100% when the recommended bacterial inoculum was doubled and the test was read strictly after 120 min of incubation. The Rapidec Carba NP test is a useful tool for the reliable confirmation of carbapenemase-producing Enterobacteriaceae isolates. The test should be read strictly after 120 min of incubation and the inoculum should be larger than recommended by the manufacturer.
authors.affiliation: Institut für Medizinische Mikrobiologie, Universität Zürich, Zurich, Switzerland mhombach@imm.uzh.ch.
authors.forename: Michael
authors.initials: M
authors.lastname: Hombach
authors.affiliation: Viollier AG, Basel, Switzerland.
authors.forename: Barbara
authors.initials: B
authors.lastname: von Gunten
authors.affiliation: Institut für Medizinische Mikrobiologie, Universität Zürich, Zurich, Switzerland.
authors.forename: Claudio
authors.initials: C
authors.lastname: Castelberg
authors.affiliation: Institut für Medizinische Mikrobiologie, Universität Zürich, Zurich, Switzerland.
authors.forename: Guido V
authors.initials: GV
authors.lastname: Bloemberg
mesh_terms: D001426:Bacterial Proteins / Q000032:analysis*; D001431:Bacteriological Techniques / Q000379:methods*; D004755:Enterobacteriaceae / Q000201:enzymology* / Q000302:isolation & purification / Q000378:metabolism*; D004756:Enterobacteriaceae Infections / Q000382:microbiology; D006801:Humans; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D013997:Time Factors; D001618:beta-Lactamases / Q000032:analysis*
chemical_list: D001426:Bacterial Proteins; D001618:beta-Lactamases; C063912:carbapenemase