article · Journal of Molecular Diagnostics
The spread of carbapenemase-producing bacteria presents an urgent global challenge requiring rapid detection to guide targeted antibiotic treatments and limit transmission. A comparative study evaluated five diagnostic assays across an international collection of 159 bacterial isolates, comprising 93 carbapenemase-producing and 66 non-producing samples. The tested assays included mCIM, CARBA-5, GeneXpert Carba-R, BD MAX Check-Points CPO, and GeneFields CPE. The mCIM assay achieved complete accuracy, sensitivity, and specificity of 100 percent. CARBA-5 achieved 98.7 percent accuracy and 100 percent specificity. GeneXpert Carba-R and BD MAX Check-Points CPO demonstrated overall accuracies of 96.9 percent and 94.3 percent respectively, whilst GeneFields CPE reached 86.2 percent accuracy. For detecting specific target genes, mCIM and CARBA-5 scored 100 percent across all performance metrics, with the remaining assays also showing high accuracy. A newly proposed scheme integrates these diagnostic tools to improve precision and testing efficiency in clinical practice.
Carbapenemase-producing bacteria resist vital frontline antibiotics, posing severe threats to patient health and infection control. Rapid and accurate detection is essential for selecting appropriate antibiotic therapies and preventing clinical outbreaks. By rigorously benchmarking five major diagnostic tools and proposing a streamlined application scheme, this research helps healthcare laboratories choose and deploy reliable testing methods to combat antimicrobial resistance effectively.
The findings directly apply to clinical diagnostic laboratories, hospital pathology departments, and public health facilities selecting commercial diagnostic platforms for drug-resistant bacteria. Because the study evaluates commercially available and established laboratory assays alongside an implementation scheme, the application pathway is near-market and ready for immediate clinical validation. Diagnostic managers can use these performance benchmarks to design cost-effective, high-accuracy testing workflows in hospital settings.
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The escalating problem of the dissemination of carbapenemase-producing bacteria (CPB) has gained worldwide attention. The prompt diagnosis of CPB and precise identification of carbapenemases are imperative to enable specific antibiotic therapy and control the spread of these bacteria. The present study was designed to assess the performance of five important assays for the detection of carbapenemases. The modified carbapenem inactivation method (mCIM), CARBA-5, GeneXpert Carba-R, BD MAX Check-Points CPO, and GeneFields CPE assays were evaluated with an international collection of 159 bacterial isolates, including 93 CPB and 66 non-CPB isolates. The overall accuracy/sensitivity/specificity for carbapenemase detection were 100% (95% CI, 97.7%-100%)/100% (95% CI, 96.1%-100%)/100% (95% CI, 94.6%-100%) for mCIM, 98.7% (95% CI, 95.5%-99.9%)/97.9% (95% CI, 92.5%-99.7%)/100% (95% CI, 94.6%-100%) for CARBA-5, 96.9% (95% CI, 92.8%-99%)/95.7% (95% CI, 89.4%-98.8%)/98.5% (95% CI, 91.8%-99.9%) for GeneXpert Carba-R, 94.3% (95% CI, 89.5%-97.4%)/90.3% (95% CI, 82.4%-95.5%)/100% (95% CI, 94.6%-100%) for BD MAX Check-Points CPO, and 86.2% (95% CI, 79.8%-91.1%)/77.4% (95% CI, 67.6%-85.5%)/98.5% (95% CI, 91.8%-100%) for GeneFields CPE. Interestingly, mCIM and CARBA-5 assays showed 100% accuracy/sensitivity/specificity for detection of the target genes. Furthermore, all the other assays showed comparable high accuracy (96.9% to 100%), sensitivity (100%), and specificity (96.4% to 100%) for the detection of the target genes. On the basis of these results, a new scheme was proposed for their efficient application. These results confirmed the high sensitivity of the evaluated assays, and the proposed scheme is reliable and improves the overall sensitivity and specificity of the assays.
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DOI: 10.1016/j.jmoldx.2020.05.012
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