Performance accuracy of antibacterial and antifungal susceptibility test methods: report from the College of American Pathologists Microbiology Surveys Program (2001-2003).

CONTEXT: The College of American Pathologists Microbiology Surveys Program provides external proficiency samples that monitor the performance of nearly 3000 laboratories that perform and report antimicrobial susceptibility tests.
OBJECTIVE: To summarize results obtained with bacterial and yeast challenge samples (2001 through 2003).
DESIGN: One organism every 4 months was tested by surveys participants against antibacterials/antifungals by routinely used methods. Reports were graded by interpretive category (susceptible, intermediate, resistant) based on an 80% consensus of referees/participants.
RESULTS: The most common antibacterial test methods/systems were Vitek (38%-43%), MicroScan (39%-43%), and the disk diffusion test (14%-15%), although Etest was most used for fastidious species. YeastOne was the dominant antifungal test (50%-55%). Antifungal results demonstrated continuous, improved accuracy (83%-88%), highest for YeastOne (96%) and broth microdilution (95%) methods. Antibacterial test accuracy was consistently greater than 97% against gram-positive organism challenges and greater than 98% against gram-negative challenges. For gram-negative strains with well-characterized resistance mechanisms, the accuracy by method was disk diffusion greater than broth microdilution greater than automated systems. Major problems identified were (1) Haemophilus influenzae control ranges require re-evaluation, (2) overuse of beta-lactamase tests, (3) errors among Enterococcus faecium against penicillins (Vitek 2, MicroScan), (4) false-susceptible results with trimethoprim/sulfamethoxazole against coagulase-negative staphylococci (MicroScan), (5) macrolide false-susceptibility for beta-hemolytic streptococcus (MicroScan), (6) flawed reporting for antimicrobials not active at the infection site, (7) use of outdated interpretive criteria, and (8) failure to follow Clinical and Laboratory Standards Institute testing/reporting recommendations.
CONCLUSIONS: Susceptibility tests were generally performing satisfactorily as measured by the surveys, but serious errors were identified with some drug/organism combinations that may require action by the Clinical and Laboratory Standards Institute and/or the Food and Drug Administration.