Interpretive standards and quality control limits for susceptibility tests with ampicillin-sulbactam combination disks

In vitro studies were performed to evaluate susceptibility tests with disks containing 10 micrograms of ampicillin plus 10 micrograms of sulbactam. Interpretive zone standards of less than or equal to 11 mm (resistant), 12 to 13 mm (intermediate), and greater than or equal to 14 mm (susceptible) are proposed. A nine-laboratory coordinated study was performed to establish tentative zone size limits for quality control of ampicillin-sulbactam disks. This included data with a new control strain selected to monitor performance of such combination disks.     

Interpretive standards and quality control guidelines for cefpiramide disk susceptibility tests.

Disk susceptibility tests with 30- and 75-micrograms cefpiramide disks were evaluated with 614 bacterial isolates. Quality control parameters were also evaluated, and control limits for disk tests are recommended. Tests with 75-micrograms disks are recommended, with zone size standards of greater than or equal to 19 mm for susceptible (MIC, less than or equal to 32 micrograms/ml) and less than or equal to 15 mm for resistant (MIC, greater than or equal to 128 micrograms/ml).     

Quality control of susceptibility tests with 5-micrograms trimethoprim disks

In 1981 and again in 1984, we performed multi-laboratory studies to develop quality control limits for susceptibility tests with 5-micrograms trimethoprim disks. Zone size limits of 21 to 28 mm are recommended for tests with Escherichia coli ATCC 25922, and limits of 19 to 26 mm are recommended for tests with Staphylococcus aureus ATCC 25923. For screening Mueller-Hinton agar, tests with Streptococcus faecalis ATCC 33186 or ATCC 29212 are recommended: zones should be fairly clear and greater than or equal to 22 mm (trimethoprim disks) or greater than or equal to 24 mm (trimethoprim-sulfamethoxazole disks).     

Quality control parameters for susceptibility tests with 30-micrograms netilmicin disks.

A nine-laboratory cooperative study was performed to evaluate quality control parameters for susceptibility tests with 30-micrograms netilmicin disks. The applicability of currently recommended zone-size limits was confirmed. However, alternative statistical methods suggested that tighter control limits might be more appropriate but would require better standardization of reagents, especially Mueller-Hinton agars.     

Disk agar diffusion susceptibility testing with 30-micrograms ceftazidime disks: confirmation of interpretive breakpoints and quality control guidelines

Ceftazidime is a wide-spectrum, beta-lactamase-stable cephalosporin with remarkable potency against Pseudomonas spp., Enterobacteriaceae, and some gram-positive species. The reevaluation of the 30-micrograms ceftazidime disk diffusion tests with commercially prepared disks confirms the proposed susceptibility breakpoint zone of greater than or equal to 17 mm (minimal inhibitory concentration correlate, less than or equal to 8.0 micrograms/ml) and the resistance breakpoint zone of less than or equal to 13 mm (minimal inhibitory concentration correlate, greater than or equal to 32 micrograms/ml). Major and minor interpretive errors were only 4.4%, and these errors could be further reduced to 1.1% by not testing gram-positive organisms, particularly enterococci and Staphylococcus spp. On the basis of the results from a multilaboratory quality control study, the following zone diameter quality control guidelines are suggested: Escherichia coli ATCC 25922, 27 to 31 mm; Staphylococcus aureus, ATCC 25923, 16 to 20 mm; Pseudomonas aeruginosa ATCC 27853, 24 to 28 mm.     

Interpretive criteria and quality control for antimicrobial susceptibility tests of levofloxacin

To confirm preliminary interpretive breakpoints for prototype 5 µg levofloxacin disks, 490 strains were tested in vitro using commercially manufactured disks. For in vitro susceptibility testing, 5 µg levofloxacin disks can be used with interpretive criteria of 12 mm for resistant (MIC 8.0 µg/ml) and 16 mm for susceptible (MIC 2.0 µg/ml). Proposed quality control limits for tests of levofloxacin are as follows:Escherichia coli ATCC 25922, zones 29–37 mm or MIC 0.008–0.03 µg/ml;Pseudomonas aeruginosa ATCC 27853, zones 19–26 mm or MIC 0.5–2.0 µg/ml;Staphylococcus aureus ATCC 25923, zones 24–31 mm;Staphylococcus aureus ATCC 29213, MIC 0.06–0.25 µg/ml andEnterococcus faecalis ATCC 29212, MIC 0.25–2.0 µg/ml.     

Interpretive criteria and tentative quality control limits for apalcillin disk susceptibility tests.

In vitro studies with 661 bacterial isolates were performed to establish interpretive criteria. In addition, a nine-laboratory study was performed to establish quality control limits for tests with 100-micrograms apalcillin disks and to confirm testing criteria for tests with 100-micrograms piperacillin disks. The two drugs were very similar, and nearly identical criteria were recommended for interpretation and for control of the two types of disks. Neither disk is recommended for testing Staphylococcus spp. or Haemophilus spp.; with other microorganisms, zone size limits of less than or equal to 13 mm (resistant) and greater than or equal to 18 mm (susceptible) are proposed for tests with 100-micrograms apalcillin disks.     

Interpretive criteria and quality control guidelines for Neisseria gonorrhoeae susceptibility test standardization for cefotetan.

Cefotetan was tested in a multilaboratory study to standardize susceptibility testing criteria and quality control guidelines for Neisseria gonorrhoeae. Cefotetan was most active against penicillinase-producing and penicillin-susceptible strains (MIC for 50% of strains tested, 0.5 micrograms/ml) and was least active against the chromosomally resistant isolates (MIC for 50% of strains tested, 2 micrograms/ml). The recommended 30-micrograms disk cefotetan interpretive criteria were as follows: susceptible at greater than or equal to 26 mm (less than or equal to 2 micrograms/ml), intermediate at 20 to 25 mm (4 micrograms/ml), and resistant at less than or equal to 19 mm (greater than or equal to 8 micrograms/ml). Quality control guidelines for agar dilution and disk diffusion tests were established by using numerous GC agar lots, three cefotetan 30-micrograms disk lots, two quality control organisms, and a volume of tests consistent with National Committee for Clinical Laboratory Standards M23-T guidelines.     

Proposed quality control guidelines for antimicrobial susceptibility tests using tilmicosin.

Quality control guidelines for tilmicosin, a novel veterinary-use-only macrolide, were developed in a multi-laboratory study according to established National Committee for Clinical Laboratory Standards (NCCLS) procedures (M23-T2). Tilmicosin was incorporated into Sensititre plates for broth microdilution endpoint testing and into two lots of 15-micrograms disks for Kirby-Bauer agar disk diffusion testing. One common lot and five unique lots of Mueller-Hinton media were used. (Broth was cation adjusted, and agar was supplemented with 5% defibrinated sheep blood.) Bacteria used for reference strains included Pasteurella haemolytica 128K, Pasteurella multocida ATCC 43137, and Staphylococcus aureus ATCC 29213 (microdilution) and ATCC 25923 (disk). Replicate tests were conducted. Disk diffusion and broth microdilution quality control ranges are proposed.     

Criteria for disk susceptibility tests and quality control guidelines for the cefoperazone-sulbactam combination.

For in vitro susceptibility tests with cefoperazone and sulbactam (a beta-lactamase inhibitor), 75/30-micrograms disks may be used with the interpretive zone size breakpoints that are currently used for 75-micrograms cefoperazone disks. For dilution tests, a 2:1 ratio of cefoperazone to sulbactam is recommended. For quality control purposes, MIC limits that are used to monitor cefoperazone tests were also applied to tests with the combination of drugs. For gram-negative control strains, zone size limits were calculated to be 1 mm smaller than those used for cefoperazone disks. To monitor the sulbactam portion of the combination, Acinetobacter calcoaceticus subsp. anitratus ATCC 43498 was selected; zones with 75/30-micrograms disks were 26 to 32 mm in diameter, and broth microdilution MICs ranged from 1.0/0.5 to 8.0/4.0 micrograms/ml. With cefoperazone alone, MICs for Acinetobacter calcoaceticus subsp. anitratus were 16 to 64 micrograms/ml and zones ranged from 14 to 18 mm in diameter. For anaerobic dilution tests, only Bacteroides thetaiotaomicron ATCC 29741 is recommended for cefoperazone-sulbactam; MICs ranged from 8.0/4.0 to 32/16 micrograms/ml.     

Interpretive criteria and quality control limits for ceftibuten disk susceptibility tests. Collaborative Antimicrobial Susceptibility Testing Group.

In vitro studies were undertaken to evaluate susceptibility tests with 30-micrograms ceftibuten disks. The following interpretive criteria were proposed: less than or equal to 17 mm for resistance (MIC, greater than or equal to 32 micrograms/ml) and greater than or equal to 21 mm for susceptibility (MIC, less than or equal to 8.0 micrograms/ml). A multilaboratory quality control study led to the conclusion that Escherichia coli ATCC 25922 should provide zones 29 to 35 mm in diameter.     

Ciprofloxacin disk susceptibility tests: interpretive zone size standards for 5-microgram disks.

Evaluations of 5-microgram ciprofloxacin disk diffusion susceptibility tests were performed independently by seven different investigators. The results of the separate tests were combined to increase the number of resistant strains in the challenge set of microorganisms. Based on data with 2,652 isolates, the following interpretive breakpoints are tentatively proposed for use in ongoing clinical trials of ciprofloxacin: less than or equal to 15 mm, resistant (MIC greater than 2.0 micrograms/ml); 16 to 20 mm, intermediate (1.0 less than MIC less than or equal to 2.0 micrograms/ml); and greater than or equal to 21 mm, susceptible (MIC less than or equal to 1.0 micrograms/ml). Disk tests with Streptococcus spp. and with Pseudomonas maltophilia were not reliable; other microorganisms were accurately categorized by the disk diffusion test.     

Interpretive criteria and quality control parameters for determining bacterial susceptibility to fosfomycin tromethamine

Studies with fosfomycin tromethamine disks containing 200 µg of fosfomycin and 50 µg of glucose-6-phosphate confirmed the following zone diameter criteria for the NCCLS method: 12 mm for resistant (MIC256 µg/ml), 13–15 mm for intermediate (MIC 128 µg/ml) and 16 mm for susceptible (MIC64 µg/ml). Additional studies defined acceptable MIC and zone diameter ranges for the following quality control strains:Escherichia coli ATCC 25922, MIC 0.5 to 4.0 µg/ml, zone diameter 23 to 29 mm;Staphylococcus aureus ATCC 25923, zone diameter 26 to 32 mm;Pseudomonas aeruginosa ATCC 27813, MIC 2.0 to 8.0 µg/ml; andEnterococcus faecalis, ATCC 29212, MIC 16 to 64 µg/ml.     

Interpretive criteria and quality control limits for testing susceptibility of Neisseria gonorrhoeae to enoxacin.

For testing the susceptibility of Neisseria gonorrhoeae to enoxacin, a proposed susceptibility category includes strains for which MICs are less than or equal to 0.5 micrograms/ml and zones of inhibition are greater than or equal to 32 mm in diameter. Because of the sparcity of resistant gonococci, a resistance category was not defined, but laboratory-selected resistant mutants were appropriately categorized by the proposed criteria. A review of clinical data confirmed the utility of a single 400-mg oral dose of enoxacin for treating gonorrhea caused by strains judged to be susceptible by the proposed criteria. For quality control purposes, for N. gonorrhoeae ATCC 49226 MICs should be 0.016 to 0.06 micrograms/ml and zones of inhibition should be 43 to 51 mm in diameter.     

Azlocillin, a ureido penicillin active against Pseudomonas aeruginosa: interpretive zone standards and quality control parameters for tests with 75-mu g disks.

A nine-laboratory coordinated study was performed to establish tentative control limits for 75-mu g azlocillin disks tested against the standard control strain of Pseudomonas aeruginosa (ATCC 27853). Control limits for individual tests were 24 to 30 mm (25 to 29 mm for means of five separate tests). To establish interpretive zone standards for 75-mu g azlocillin disks, three separate laboratories each tested 93 strains of P. aeruginosa or related species. Geometric mean minimal inhibitory concentrations (MICs) were plotted against arithmetic mean zone diameters. Regression analyses were performed with zone diameter as the independent variable and also with MIC as the independent variable. The following interpretive categories were recommended: resistant, less than or equal to 14 mm (MIC, greater than 128 mu g/ml); intermediate, 15 to 17 mm (MIC, 128 mu g/ml); and susceptible, greater than or equal to 18 mm (MIC, less than or equal to 64 mu g/ml).