Traceability of Calibration for IVD Industry: Process for Credentialing Reference Materials, Reference Methods and Reference Laboratories in Europe

摘要

The concept of measurement traceability has been established in general chemical metrology and is now also being introduced to the field of clinical chemical analyses. Traceability provides probably the most important strategy to achieve standardisation in laboratory medicine aimed at comparable measurement results regardless of the method, the measurement procedure (test kit) and of the laboratory where analyses are carried out.