Pfaller M A, Boyken L, Messer S A, Tendolkar S, Hollis R J, Diekema D J
Department of Pathology, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, IA 52242, USA.
J Clin Microbiol. 2005 Oct;43(10):5208-13. doi: 10.1128/JCM.43.10.5208-5213.2005.
The accuracy of antifungal susceptibility testing is important for reliable resistance surveillance and for the clinical management of patients with serious infections. Our primary objective was to compare the results of voriconazole disk diffusion testing of Candida spp. performed by centers participating in the ARTEMIS program with disk diffusion and MIC results obtained by the central reference laboratory. A total of 2,934 isolates of Candida spp. were tested by CLSI disk diffusion and reference broth microdilution methods in the central reference laboratory. These results were compared to the results of disk diffusion testing performed in the 54 participating centers. All tests were performed and interpreted following CLSI recommendations, as follows: susceptible (S), MIC of <or=1 microg/ml (>or=17 mm); susceptible dose dependent (SDD), MIC of 2 microg/ml (14 to 16 mm); and resistant (R), MIC of >or=4 microg/ml (<or=13 mm). The overall categorical agreement between participant disk diffusion test results and reference laboratory MIC results was 94.1%, with 0.1% very major errors (VME) and 3.4% major errors (ME). The categorical agreement between disk diffusion test results obtained in the reference laboratory and the MIC test results was 99.0%. Likewise, good agreement was observed between participant disk diffusion test results and reference laboratory disk diffusion test results, with an agreement of 93.8%, 0.2% VME, and 3.4% ME. The disk diffusion test was reliable for detecting those isolates of Candida spp. that were characterized as resistant (MIC of >or=4 microg/ml) by MIC testing. External quality assurance data obtained by surveillance programs such as the ARTEMIS Global Antifungal Surveillance Program ensure the generation of useful surveillance data and result in the continued improvement of antifungal susceptibility testing practices.
抗真菌药敏试验的准确性对于可靠的耐药性监测以及严重感染患者的临床管理至关重要。我们的主要目标是比较参与ARTEMIS项目的各中心对念珠菌属进行伏立康唑纸片扩散法检测的结果，与中央参考实验室通过纸片扩散法和MIC检测获得的结果。中央参考实验室采用CLSI纸片扩散法和参考肉汤微量稀释法对总共2934株念珠菌属菌株进行了检测。将这些结果与54个参与中心进行的纸片扩散法检测结果进行比较。所有检测均按照CLSI建议进行操作和判读，具体如下：敏感（S），MIC≤1μg/ml（抑菌圈直径≥17mm）；剂量依赖性敏感（SDD），MIC为2μg/ml（抑菌圈直径14至16mm）；耐药（R），MIC≥4μg/ml（抑菌圈直径≤13mm）。参与中心的纸片扩散试验结果与参考实验室MIC结果的总体分类一致性为94.1%，极重大错误（VME）为0.1%，重大错误（ME）为3.4%。参考实验室获得的纸片扩散试验结果与MIC试验结果之间的分类一致性为99.0%。同样，参与中心的纸片扩散试验结果与参考实验室的纸片扩散试验结果之间也观察到良好的一致性，一致性为93.8%，VME为0.2%，ME为3.4%。纸片扩散试验对于检测那些通过MIC检测被判定为耐药（MIC≥4μg/ml）的念珠菌属菌株是可靠的。通过ARTEMIS全球抗真菌监测项目等监测计划获得的外部质量保证数据确保了有用监测数据的产生，并促使抗真菌药敏试验方法不断改进。
