The statistical basis of standardization designs for diagnostic assays

被引:0
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作者
Andrea Konnert
Christoph Berding
机构
[1] University Ulm and Biometry Roche Diagnostics GmbH,Faculty of Mathematics and Economics
[2] Biometry,undefined
[3] Roche Diagnostics GmbH,undefined
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关键词
Standardization design; Value assignment; Analysis of variance; Outlier analysis;
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摘要
Accuracy and long-term quality of laboratory diagnostic assays depend critically on the standardization process. In this note we review statistically typical procedures and designs used in standardization. Issues of practical relevance such as the number of systems, runs, and replicates to be involved in the standardization design, and quality control aspects, are addressed.
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页码:457 / 463
页数:6
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