[Establishment of working reference materials in laboratory medicine].

It is recognized that the establishment of reference materials is the most important factor for standardization in laboratory medicine. In particular, working reference materials for routine measurement procedures are effective tools to maintain the commutability of measured values. Working reference materials are dealt with in a traceability chain system issued by ISO 17511 (in vitro diagnostic medical devices--measurement of quantities in biological samples--metrology traceability of values assigned to calibrators and control materials). The JCCLS is strongly promoting standardization in laboratory medicine by using working reference materials. Working groups for standardization are organized by the JCCLS in cooperation with the NMIJ (National Metrology Institute of Japan) with a grant from the NEDO (New Energy and Industrial Technology Development Organization). The objective is the establishment of working reference materials for routine use. Standardization criteria using the reference materials are being established. Research and development and investigation studies of matrix reference materials have been started. In investigation studies, the production protocol of reference materials are being prepared. After being established, reference materials will be presented to the JCTLM (Joint Committee on Traceability in Laboratory Medicine). These activities will enhance standardization in laboratory medicine. As a results, they will contribute to maintaining the reliability of measured values in routine laboratory procedures.