Gavan T L, Jones R N, Barry A L, Fuchs P C, Gerlach E H, Matsen J M, Reller L B, Thornsberry C, Thrupp L D
J Clin Microbiol. 1981 Jul;14(1):67-72. doi: 10.1128/jcm.14.1.67-72.1981.
A multilaboratory in vitro study was carried out to determine disk diffusion susceptibility testing quality control limits for two new semisynthetic penicillins, mezlocillin and piperacillin. Existing limits for carbenicillin and ampicillin were reevaluated. Multiple tests (which followed standards set by the National Committee for Clinical Laboratory Standards ASM-2 revised) were performed in nine laboratories by different technologists using disks and Mueller-Hinton agar from different manufacturers. Clinically significant differences between disks produced by different manufacturers were not noted. Inhibitory zone diameter measurements from all laboratories were analyzed, and upper and lower control limits were established by using the overall median +/-0.5 the median range of the individual laboratory measurements as determining parameters. Close agreement of the data in this study with the results of national proficiency testing and quality control programs for ampicillin and carbenicillin supports the validity of our approach to making initial recommendations for quality control guidelines for new antimicrobial agents.
开展了一项多实验室体外研究,以确定两种新型半合成青霉素(美洛西林和哌拉西林)的纸片扩散药敏试验质量控制限度。对羧苄西林和氨苄西林的现有限度进行了重新评估。九个实验室的不同技术人员按照美国国家临床实验室标准委员会(NCCLS)ASM-2修订版设定的标准,使用不同厂家生产的纸片和穆勒-欣顿琼脂进行了多次试验。未发现不同厂家生产的纸片之间存在具有临床意义的差异。分析了所有实验室的抑菌圈直径测量结果,并以各实验室测量值的总体中位数±中位数范围的0.5作为确定参数,确定了质量控制的上限和下限。本研究的数据与氨苄西林和羧苄西林国家能力验证测试及质量控制项目的结果高度一致,这支持了我们为新抗菌药物质量控制指南提出初步建议的方法的有效性。