Evaluation of NG-Test Carba 5 for Rapid Phenotypic Detection and Differentiation of Five Common Carbapenemase Families: Results of a Multicenter Clinical Evaluation.

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Tytuł:: Evaluation of NG-Test Carba 5 for Rapid Phenotypic Detection and Differentiation of Five Common Carbapenemase Families: Results of a Multicenter Clinical Evaluation.
Autorzy:: Jenkins S; Weill Cornell Medicine, New York, New York, USA.
Ledeboer NA; Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Westblade LF; Weill Cornell Medicine, New York, New York, USA.
Burnham CA; Washington University in St. Louis School of Medicine, St. Louis, Missouri, USA.
Faron ML; Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Bergman Y; Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Yee R; Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Mesich B; Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Gerstbrein D; Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Wallace MA; Washington University in St. Louis School of Medicine, St. Louis, Missouri, USA.
Robertson A; Weill Cornell Medicine, New York, New York, USA.
Fauntleroy KA; Weill Cornell Medicine, New York, New York, USA.
Klavins AS; Hardy Diagnostics, Santa Maria, California, USA.
Malherbe R; Hardy Diagnostics, Santa Maria, California, USA.
Hsiung A; Hardy Diagnostics, Santa Maria, California, USA.
Simner PJ; Johns Hopkins University School of Medicine, Baltimore, Maryland, USA .
Źródło:: Journal of clinical microbiology [J Clin Microbiol] 2020 Jun 24; Vol. 58 (7). Date of Electronic Publication: 2020 Jun 24 (Print Publication: 2020).
Typ publikacji:: Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
Język:: English
Imprint Name(s):: Original Publication: Washington, American Society for Microbiology.
MeSH Terms:: Bacterial Proteins*/genetics
beta-Lactamases*/genetics
Animals ; France ; Sensitivity and Specificity ; Sheep
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Contributed Indexing:: Keywords: Enterobacterales; NG-Test Carba 5; Pseudomonas aeruginosa; Xpert Carba-R; carbapenemase; eCIM; mCIM
Substance Nomenclature:: 0 (Bacterial Proteins)
EC 3.5.2.6 (beta-Lactamases)
EC 3.5.2.6 (carbapenemase)
Entry Date(s):: Date Created: 20200508 Date Completed: 20210623 Latest Revision: 20240329
Update Code:: 20240329
PubMed Central ID:: PMC7315033
DOI:: 10.1128/JCM.00344-20
PMID:: 32376668
: Czasopismo naukowe

NG-Test Carba 5 is a rapid in vitro multiplex immunoassay for the phenotypic detection and differentiation of five common carbapenemase families (KPC, OXA-48-like, VIM, IMP, and NDM) directly from bacterial colonies. The assay is simple to perform and has recently received U.S. Food and Drug Administration clearance. A method comparison study was performed at geographically diverse medical centers ( n = 3) in the United States, where 309 Enterobacterales and Pseudomonas aeruginosa isolates were evaluated by NG-Test Carba 5 (NG Biotech, Guipry, France), the Xpert Carba-R assay (Cepheid, Inc., Sunnyvale, CA), the modified carbapenem inactivation method (mCIM), the EDTA-modified carbapenem inactivation method, and disk diffusion with carbapenems. Colonies from tryptic soy agar with 5% sheep blood (blood agar) and MacConkey agar were tested, and the results were compared to those obtained by a composite reference method. Additionally, a fourth medical center performed a medium comparison study by evaluating the performance characteristics of NG-Test Carba 5 from blood, MacConkey, and Mueller-Hinton agars with 110 isolates of Enterobacterales and P. aeruginosa These results were compared to the expected genotypic and mCIM results. For the multicenter method comparison study, the overall positive percent agreement (PPA) and the overall negative percent agreement (NPA) of NG-Test Carba 5 with the composite reference method were 100% for both blood and MacConkey agars. The medium comparison study at the fourth site showed that the PPA ranged from 98.9% to 100% and that the NPA ranged from 95.2% to 100% for blood, MacConkey, and Mueller-Hinton agars. NG-Test Carba 5 accurately detected and differentiated five common carbapenemase families from Enterobacterales and P. aeruginosa colonies on commonly used agar media. The results of this test will support a streamlined laboratory work flow and will expedite therapeutic and infection control decisions.
(Copyright © 2020 American Society for Microbiology.)

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