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首页> 外文期刊>Antimicrobial agents and chemotherapy. >Statistical methods for establishing quality control ranges for antibacterial agents in clinical and laboratory standards institute susceptibility testing.
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Statistical methods for establishing quality control ranges for antibacterial agents in clinical and laboratory standards institute susceptibility testing.

机译：建立临床和实验室标准研究所药敏试验中抗菌剂质量控制范围的统计方法。

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Quality control (QC) ranges for antimicrobial agents against QC strains for both dilution and disk diffusion testing are currently set by the Clinical and Laboratory Standards Institute (CLSI), using data gathered in predefined structured multilaboratory studies, so-called tier 2 studies. The ranges are finally selected by the relevant CLSI subcommittee, based largely on visual inspection and a few simple rules. We have developed statistical methods for analyzing the data from tier 2 studies and applied them to QC strain-antimicrobial agent combinations from 178 dilution testing data sets and 48 disk diffusion data sets, including a method for identifying possible outlier data from individual laboratories. The methods are based on the fact that dilution testing MIC data were log normally distributed and disk diffusion zone diameter data were normally distributed. For dilution testing, compared to QC ranges actually set by CLSI, calculated ranges were identical in 68% of cases, narrower in 7% of cases, and wider in 14% of cases. For disk diffusion testing, calculated ranges were identical to CLSI ranges in 33% of cases, narrower in 8% of cases, and 1 to 2 mm wider in 58% of cases. Possible outliers were detected in 8% of diffusion test data but none of the disk diffusion data. Application of statistical techniques to the analysis of QC tier 2 data and the setting of QC ranges is relatively simple to perform on spreadsheets, and the output enhances the current CLSI methods for setting of QC ranges.
机译：临床和实验室标准协会（CLSI）目前使用预先定义的结构化多实验室研究（所谓的2级研究）中收集的数据，设置了针对稀释和圆盘扩散测试的针对QC菌株的抗菌剂的质量控制（QC）范围。有关范围最终由相关的CLSI小组委员会选择，主要基于目视检查和一些简单的规则。我们已经开发了统计方法来分析来自第2层研究的数据，并将其应用于来自178个稀释测试数据集和48个磁盘扩散数据集的QC菌株-抗菌剂组合，包括从各个实验室中识别可能的异常数据的方法。该方法基于以下事实：稀释测试MIC数据呈对数正态分布，而圆盘扩散区直径数据呈正态分布。对于稀释测试，与CLSI实际设置的质量控制范围相比，计算范围在68％的情况下相同，在7％的情况下更窄，在14％的情况下更宽。对于磁盘扩散测试，在33％的情况下，计算范围与CLSI范围相同，在8％的情况下与CLSI范围相同，在58％的情况下，其计算范围与CLSI范围相同。在8％的扩散测试数据中检测到了可能的异常值，但没有磁盘扩散数据。统计技术在质量控制二级数据分析和质量控制范围设置中的应用相对容易在电子表格上执行，并且输出增强了当前用于设置质量控制范围的CLSI方法。

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