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.     

Nonmicrobial alternative to reagent quality control testing.

The traditional approach to quality control in microbiology involves the routine testing of both media and reagents with live microbial cultures. This is expensive, time consuming, and subject to the variables associated with the use of live organisms. A system of reagent quality control based on the pure chemical form of the metabolic end products important to the identification of the Enterobacteriaceae was evaluated. The metabolite reagent control system is simple, reliable, and extremely cost effective, and it eliminates the need for live microbial cultures and media for reagent quality control.     

Multicentre determination of quality control strains and quality control ranges for antifungal susceptibility testing of yeasts and filamentous fungi using the methods of the Antifungal Susceptibility Testing Subcommittee of the European Committee on Antimicrobial Susceptibility Testing (AFST-EUCAST)

A multicentre study involving seven laboratories was performed using techniques recommended by the Antifungal Susceptibility Testing Subcommittee of the European Committee on Antimicrobial Susceptibility Testing (AFST-EUCAST) to evaluate and propose quality control ranges and strains for susceptibility testing of fermentative yeasts and filamentous fungi. Participating laboratories tested the susceptibilities of a panel of 12 encoded isolates to amphotericin B, flucytosine, fluconazole, itraconazole, voriconazole and posaconazole. In total, 15 lots of assay medium were tested, with one lot being common to all laboratories, and 18 144 MIC values were determined. Intra- and inter-laboratory agreements and intra-class correlation coefficients (ICCs) of the results for each drug/strain/lot combination were calculated. An average value of 85% agreement was selected for validation purposes. The average percentage of intra-laboratory agreement was 90-95%, with ICC values of 0.90-0.95 (p <0.01). Inter-laboratory reproducibility was also high, with 92% agreement and an ICC of 0.97 (p <0.01). The reproducibility was somewhat better with the common lot of assay medium (96% agreement) than with the different lots (91% agreement), but this difference was not significant. Two isolates that showed trailing growth had agreement percentages below the 85% limit selected for validation purposes and were therefore excluded from the panel of quality control strains. The recommended EUCAST methodologies were found to be highly reproducible and reliable for susceptibility testing of yeasts and filamentous fungi. Ten isolates are proposed for use as quality control strains with these EUCAST procedures.     

Susceptibility testing of the non-tuberculous mycobacteria

In vitro susceptibility test criteria have been defined for only a limited number of non-tuberculous mycobacteria (NTM) because definitive studies correlating in vivo outcomes with in vitro data are lacking. Another contributing factor is the assigning of a pathogenic role to the isolation of a particular NTM. Currently, clarithromycin susceptibility testing of clinically significant Mycobacterium avium complex (MAC) isolates is recommended. However, breakthrough isolates of MAC have been shown to exhibit elevated MICs to other agents the patients were receiving. More data exist with testing isolates of Mycobacterium kansasii, which can be tested in a fashion similar to that for isolates of Mycobacterium tuberculosis. There are limited recommendations for other species of slowly growing mycobacteria. Testing of rapidly growing species of mycobacteria against antibacterial agents has been shown to have some clinical utility. The methods used to perform this testing also need to be further validated.     

Internal quality control, proficiency testing, and the clinical relevance of laboratory testing

Estimates of instrument-specific analytical performance for measurement of four chemistry analytes (calcium, cholesterol, creatinine, and glucose) were derived from 21 quality control programs that utilized the College of American Pathologists Quality Assurance Service and from 12 College of American Pathologists Comprehensive Chemistry Survey sets. The quality control-derived estimates of analytical bias were larger and level-dependent when compared with the survey results. Possible explanations for these differences include "matrix effects" due to glycol stabilization of the control materials studied and analyst bias when testing survey specimens. A number of instruments from the Quality Assurance Service pools failed to meet the allowable analytical error goals for calcium and creatinine that serve as the basis for the "fixed limits" evaluation criteria of the survey program. The methods for glucose analysis met the prescribed evaluation limits. Cholesterol analyses need significant improvement to meet the analytical requirements of long-term testing of individuals.     

Proposed quality control and interpretive criteria for disk diffusion susceptibility testing with enoxacin.

The standardized disk diffusion test, in which a 10-micrograms enoxacin disk is used, was performed and microbroth dilution MICs were determined to establish individual test control values with Escherichia coli ATCC 25922, Pseudomonas aeruginosa ATCC 27853, Staphylococcus aureus ATCC 25923, and S. aureus ATCC 29213. In addition, regression analysis correlating inhibitory zone diameter with MICs for approximately 400 gram-negative clinical isolates was performed. Based on linear regression and error rate-bounded analyses, criteria for the category calls of isolates are proposed.     

Susceptibility testing of carumonam: interpretive criteria for 30-microgram disk tests and quality control guidelines for disk diffusion and broth microdilution methods.

Carumonam 30-microgram disk diffusion tests with 342 gram-negative organisms suggested modifying earlier interpretive zone criteria, i.e., a susceptibility zone diameter of greater than or equal to 23 mm (less than or equal to 8.0 micrograms/ml MIC correlate) and a resistance zone diameter of less than or equal to 17 mm (greater than or equal to 32 micrograms/ml MIC correlate). Quality assurance guidelines were determined by multilaboratory investigations. Recommended limits were calculated for the gram-negative quality control organisms only. For Escherichia coli ATCC 25922, the recommended limits are 30 to 36 mm and 0.03 to 0.25 micrograms/ml, and for Pseudomonas aeruginosa ATCC 27853, they are 24 to 32 mm and 1.0 to 4.0 micrograms/ml.