TABLE 5.
Agents for which current CLSI breakpoints are not recognized by the FDAa
| Organism group | Antimicrobial agent |
|---|---|
| Enterobacteriaceae | Cefazolin |
| Ciprofloxacin | |
| Levofloxacin | |
| Enterobacteriaceae (Salmonella) | Levofloxacin |
| Pseudomonas aeruginosa | Cefepimeb |
| Ceftazidimeb | |
| Ciprofloxacin | |
| Levofloxacin | |
| Acinetobacter spp. | Meropenem |
| S. aureus | Ceftaroline |
| Enterococcus spp. | Daptomycin |
Manufacturers of cASTs must use FDA breakpoints.
FDA updated the cefepime and ceftazidime P. aeruginosa breakpoints in 2012, whereas the CLSI did not. The current FDA breakpoint does not include an intermediate category, which makes clearance of cASTs challenging due to the higher rates of very major errors (VMEs), major errors (MEs), and results without any minor errors (mE).