Standards, Standardization and Feasibility in Clinical Chemistry and Homogeneous Immunoassays from Roche Diagnostics 罗氏诊断的临床化学和均匀免疫分析的标准化、标准化和可行性.pdf

Fundamentals in Laboratory Medicine Standards, Standardization and Feasibility in Clinical Chemistry and Homogeneous Immunoassays from Roche Diagnostics March 2003 Authors: Dr. Chr. Berding, A. Fischer, Dr. H.-D. Lessmann, Dr. B. Zawta Roche Diagnostics GmbH Mannheim/Penzberg Preface As diagnostics manufacturers at Roche Although we originally intended to Diagnostics we are often asked about limit ourselves to clinical chemis- standardization and lot-to-lot consis- try and homogeneous immunoassays, tency issues. These questions are very much of what is said in the following complex and this booklet is an at- pages is more widely applicable and tempt to provide a satisfactory answer. concerns general issues of laboratory testing. During the planning and writing, at the latest, it became clear to us that it The quality of laboratory test results is would be sensible to make a wide influenced both by us, the diagnostics sweep, from the basic mathematical manufacturer, and by you, the client/ and scientific principles to medical user. interpretation and the processes that are nowadays subsumed under the We would therefore welcome any com- term Total Quality Management. ments or suggestions for incorpora- tion in future editions of this booklet. March 2003 Dr. Christoph Berding A. Fischer Dr. H.-D. Lessmann Dr. Bernd Zawta