Accreditation and Quality Assurance

, Volume 9, Issue 8, pp 457–463

The statistical basis of standardization designs for diagnostic assays

General Paper


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.


Standardization design Value assignment Analysis of variance Outlier analysis 


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Copyright information

© Springer-Verlag 2004

Authors and Affiliations

  1. 1.Faculty of Mathematics and EconomicsUniversity Ulm and Biometry Roche Diagnostics GmbHPenzbergGermany
  2. 2.Biometry, Roche Diagnostics GmbHPenzbergGermany

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