Multicenter Evaluation of Ceftazidime-Avibactam Susceptibility Testing of Enterobacterales and Pseudomonas aeruginosa on the Vitek 2 System
| Autor: | Hari P. Dwivedi, Lisa Heimbach, Simone Franklin, Shelley Campeau, Romney Humphries, Kristin Nagaro, Vincent LaBombardi, Thomas E. Davis |
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| Rok vydání: | 2021 |
| Předmět: |
Microbiology (medical)
medicine.medical_specialty Susceptibility testing business.industry Pseudomonas aeruginosa Avibactam Broth microdilution Ceftazidime Ceftazidime/avibactam medicine.disease_cause chemistry.chemical_compound chemistry Internal medicine Enterobacterales medicine Overall performance business medicine.drug |
| Zdroj: | Journal of Clinical Microbiology. 59 |
| ISSN: | 1098-660X 0095-1137 |
| Popis: | In this multisite study, Vitek 2 AST-Gram-Negative Ceftazidime/Avibactam test results for 1,073 isolates (866 Enterobacterales and 207 Pseudomonas aeruginosa) were compared to the Clinical and Laboratory Standards Institute (CLSI) broth microdilution (BMD) reference method. The results were analyzed for essential agreement (EA), category agreement (CA), major error rates, and very major error rates following FDA/ISO performance criteria using the FDA-recognized CLSI/EUCAST breakpoints (sensitive [S], ≤8/4 μg/ml; resistant [R], ≥16/4 μg/ml). The overall EA was 94.5% (1,014/1,073) and CA was 98.7% (1,059/1,073). No very major errors were reported. The major error rate was 1.4% (14/998). Out of 14 major errors, 9 were within EA. Based on the EA and lack of an intermediate category for ceftazidime-avibactam (CZA), the adjusted major error rate for FDA criteria was 0.5% (5/998). The performance for ISO criteria after error resolutions included EA of 94.5% (1,014/1,073), CA of 98.9% (1,061/1,073), major error of 1.2% (12/998), and no very major error. Vitek 2 met the ISO and FDA criteria of ≥95% reproducibility and ≥95% quality control (QC) results within acceptable ranges for QC organisms. Vitek 2 overall performance for Enterobacterales and P. aeruginosa met or exceeded the FDA and ISO performance criteria; thus, it is a reliable alternative to the BMD reference method for routine CZA susceptibility testing. |
| Databáze: | OpenAIRE |
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