Oosterhuis Wytze P, Severens Michel J
Zuyderland Medical Center, Department of Clinical Chemistry and Hematology, Sittard, The Netherlands.
Zuyderland Medical Center, Department of Clinical Chemistry and Hematology, Sittard, The Netherlands.
Clin Biochem. 2018 Jul;57:12-17. doi: 10.1016/j.clinbiochem.2018.04.002. Epub 2018 Apr 11.
Analytical performance specifications are crucial in test development and quality control. Although consensus has been reached on the use of biological variation to derive these specifications, no consensus has been reached which model should be preferred. The Six Sigma concept is widely applied in industry for quality specifications of products and can well be compared with Six Sigma models in clinical chemistry. However, the models for measurement specifications differ considerably between both fields: where the sigma metric is used in clinical chemistry, in industry the Number of Distinct Categories is used instead. In this study the models in both fields are compared and discussed.
