Abstract
BackgroundPrompt and accurate identification of carbapenemase production is essential for appropriate treatment and infection control. NG-Test Carba 5 (termed herein “Carba 5”; NG Biotech, Guipry, France) is a multiplex immunochromatographic assay for the rapid phenotypic identification of five major carbapenemases (KPC, NDM, VIM, IMP, and OXA-48-like) from bacterial isolates. This study aimed to evaluate the diagnostic performance of Carba 5 and its impact on the turn-around-time in a clinical microbiology laboratory.ResultsCarba 5 was retrospectively evaluated using 78 carbapenemase producers and 23 non-carbapenemase producers confirmed by PCR and sequencing. The performance and time required for carbapenemase identification were prospectively evaluated using 47 carbapenem resistant Enterobacteriaceae isolates, and the results were compared to those obtained using Xpert Carba-R (Cepheid, Sunnyvale, CA, USA). For the bacterial isolates included in retrospective and prospective evaluation, the Carba 5 assay correctly identified 147 isolates except one isolate with a sensitivity of 99.13% (95% CI 95.25–99.98%) and specificity of 100% (95% CI 89.42–100%). The Carba 5 assay missed one VIM-1 among 13 VIM producers. The assay showed a sensitivity of 92.31% (95% CI 63.97–99.81%) for detecting VIM and 100% for detecting KPC, NDM, OXA-48-like, and IMP. Compared to the Xpert Carba-R assay, Carba 5 exhibited 100% agreement and was more time-efficient (median time 24 min vs. 1 h 11 min).ConclusionsThe Carba 5 assay has potential as an alternative to molecular methods for detecting major carbapenemases from bacterial isolates in a clinical microbiology laboratory. Compared to the Xpert Carba-R, Carba 5 turns out to be more affordable and time-efficient while showing a comparable performance, and may accelerate therapeutic and infection control decisions.
Highlights
Prompt and accurate identification of carbapenemase production is essential for appropriate treatment and infection control
This study aimed to evaluate the diagnostic performance of the Carba 5 assay, including its sensitivity and specificity for the detection of five major carbapenemases, and to evaluate the time efficiency of the Carba 5 assay by analyzing the time required for detecting carbapenemase in a routine microbiology laboratory setting
Retrospective analysis of the Carba 5 assay The Carba 5 assay showed an overall sensitivity of 98.72% (95% confidence interval (CI) 93.06–99.97%) and a specificity of 100% for the identification of five carbapenemases that the assay targeted
Summary
Prompt and accurate identification of carbapenemase production is essential for appropriate treatment and infection control. NG-Test Carba 5 (termed “Carba 5”; NG Biotech, Guipry, France) is a multiplex immunochromatographic assay for the rapid phenotypic identification of five major carbapenemases (KPC, NDM, VIM, IMP, and OXA-48-like) from bacterial isolates. Prompt and accurate identification of carbapenemase-producing organisms (CPOs) is essential for preventing further spread and infection control [3,4,5]. For the rapid detection and characterization of carbapenemases in bacterial isolates, several commercialized colorimetric tests have been developed, which provide results in 30 to 120 min. They have shown variable performance depending on the carbapenemase activity [8, 9]. PCR-based POC assays take about an hour, it can substantially reduce the turn-around time in carbapenemase detection compared to targeted PCRbased methods
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