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首页> 外文期刊>Scandinavian journal of clinical and laboratory investigation. >Allowable systematic difference between two instruments measuring the same analyte
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Allowable systematic difference between two instruments measuring the same analyte

机译：测量同一分析物的两种仪器之间允许的系统差异

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Background. If a laboratory has two analytical instruments for measuring the concentration of the same analyte and samples from the patients are randomly allocated to either of the two, then an allowable systematic difference between the two instruments should be defined. We present a solution to this problem, based on the traditional criterion that the total analytical standard deviation (SD) shall be less than half the within-subject biological SD. Methods. We derived a formula for estimating the SD of the distribution of analytical results that may stem from two instruments with different means and SDs and different probabilities of being used. The formula was used to estimate the allowable systematic difference between the two instruments. Results. The allowable systematic difference depends on the within-subject biological SD, the SDs of the two instruments, and the probability that a sample is analyzed with a certain instrument. When this probability is 0.5, the allowable systematic difference approaches the magnitude of the within-subject biological SD as the analytical SDs approach zero, while no systematic difference is allowed when the two analytical SDs are equal to their maximum allowable value of half the within-subject biological SD. Conclusions. In a monitoring situation, the allowable systematic difference between two analytical instruments depends on the probability that a sample is allocated to each of the instruments as well as the analytical SDs and the within-subject biological SD.
机译：背景。如果实验室有两个用于测量同一分析物浓度的分析仪器，并且将来自患者的样品随机分配到这两个仪器中的任何一个，则应在这两个仪器之间定义一个允许的系统差异。我们基于传统标准（总分析标准偏差（SD）应小于受试者内部生物学SD的一半）提出解决方案。方法。我们推导了一个公式，用于估计分析结果分布的标准差，该标准可能源自两种具有不同均值和标准差以及使用概率不同的仪器。该公式用于估计两种工具之间的允许系统差异。结果。允许的系统差异取决于受试者内部的生物学SD，两种仪器的SD以及使用某种仪器分析样品的可能性。当此概率为0.5时，当分析SD接近零时，允许的系统差异接近受试者内部生物SD的大小，而当两个分析SD等于其最大允许值一半时，则不允许系统差异。主题生物学SD。结论在监视情况下，两种分析仪器之间允许的系统差异取决于将样品分配给每种仪器以及分析标准物和受试者体内生物标准物的可能性。

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