, Volume 9, Issue 8, pp 457-463
Date: 16 Jun 2004

The statistical basis of standardization designs for diagnostic assays

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Abstract

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.