TABLE 2.
Breakpoints for interpretation of MICs and zone diameters approved by EUCAST (version 10.0, valid from January 2020), FDA, and CLSI (M100 30th edition, valid from January 2020)a
Antibiotic(s) | EUCAST |
FDA |
CLSI |
|||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
MIC (mg/liter) |
Zone diameter (mm) |
MIC (mg/liter) |
Zone diameter (mm) |
MIC (mg/liter) |
Zone diameter (mm) |
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S | I | R | S | I | R | S | I | R | S | I | R | S | I | R | S | I | R | |
CAZ-AVI for zone diameter breakpoints, disk content 10/4 μg (EUCAST), 30/20 μg/ml (CLSI/FDA) | ||||||||||||||||||
Enterobacterales | ≤8b | >8b | 13 | 13 | M100c | ≤8/4 | ≥16/4 | ≥21d | ≤20c | |||||||||
P. aeruginosa | 8b | 8b | 17 | 17 | M100 | ≤8/4 | ≥16/4 | ≥21 | ≤20 | |||||||||
TOL-TAZ for zone diameter breakpoints, disk content 30/10 μg/ml (EUCAST/FDA/CLSI) | ||||||||||||||||||
Enterobacterales | ≤2e | >2e | 22 | 22 | M100 | >22 | 19–21 | <18 | ≤2/4 | 4/4 | ≥8/4 | ≥21 | 18–20 | ≤17 | ||||
P. aeruginosa | ≤4e | >4e | 24 | 24 | M100 | ≤4/4 | 8/4 | ≥16/4 | ≥21 | 17–20 | ≤16 | |||||||
Haemophilus influenzae (pneumonia) | ≤0.5e | >0.5e | IP | IP | ≤0.5/4 | |||||||||||||
Streptococcus viridans group | IE | IE | IE | IE | M100 | ≤8/4 | 16/4 | ≥32/4 | ||||||||||
Bacteroides fragilis | ≤8/4 | 16/4 | ≥32/4 | |||||||||||||||
MER-VAB for zone diameter breakpoints, disk content 20/10 μg/ml (CLSI/FDA) | ||||||||||||||||||
Enterobacterales | ≤8f | >8f | IP | IP | M100 | ≤4/8 | 8/8 | ≥16/8 | ≥18 | 15–17 | ≤14 | |||||||
P. aeruginosa | 8f | 8f | IP | IP | ||||||||||||||
IMI-REL for zone diameter breakpoints, disk content 10/25 μg/ml (FDA) | ||||||||||||||||||
Enterobacteralesg | ≤2h | >2h | IP | IP | ≤1/4 | 2/4 | ≥4/4 | ≥25 | 21–24 | ≤20 | ||||||||
P. aeruginosa | ≤2h | >2h | IP | IP | ≤2/4 | 4/4 | ≥8/4 | ≥23 | 20–22 | ≤19 | ||||||||
Acinetobacter spp. | ≤2h | >2h | IP | IP | ||||||||||||||
Viridans group streptococci | ≤2h | >2h | IP | IP | ||||||||||||||
Gram-positive anaerobes | ≤2h | >2h | ≤4/4i | 8/4i | ≥16/4i | |||||||||||||
Gram-negative anaerobes | ≤2h | >2h | ≤4/4i | 8/4i | ≥16/4i |
CAZ-AVI, ceftazidime/avibactam; TOL-TAZ, ceftolozane/tazobactam; MER-VAB, meropenem/vaborbactam; IMI-REL, imipenem/relebactam; IP, in preparation; IE, insufficient evidence. The respective dosages for each β-lactam/β-lactamase inhibitor are shown in Table 3.
For susceptibility testing purposes, the concentration of avibactam is fixed at 4 mg/liter.
M100 standard is recognized.
Confirmatory MIC testing is indicated for isolates with zones of 20 to 22 mm to avoid reporting false-susceptible or false-resistant results.
For susceptibility testing purposes, the concentration of tazobactam is fixed at 4 mg/liter.
For susceptibility testing purposes, the concentration of vaborbactam is fixed at 8 mg/liter.
EUCAST-approved breakpoints for Enterobacteriales, except Morganella spp.; FDA-approved breakpoints for Enterobacteriaceae: clinical efficacy was shown for Klebsiella aerogenes, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, and Klebsiella oxytoca.
For susceptibility testing purposes, the concentration of relebactam is fixed at 4 mg/liter.
FDA-approved breakpoints for anaerobes using agar dilution method, clinical efficacy shown for Bacteroides caccae, Bacteroides fragilis, Bacteroides ovatus, Bacteroides stercoris, Bacteroides thetaiotaomicron, Fusobacterium nucleatum, and Parabacteroides distasonis.