Challenge to Coordinate Harmonization Activities on an International Level.

Abstract

In this issue of Clinical Chemistry , Dr. Little and coauthors describe the situation where several research efforts to harmonize C-peptide were started independently of each other and the challenges subsequently encountered with implementing a reference measurement system for calibration traceability of C-peptide (1). In the US, a National Institutes of Health-sponsored standardization program developed a reference measurement procedure that was listed by the Joint Committee for Traceability in Laboratory Medicine (JCTLM), and qualified a panel of pooled serum reference materials for use as secondary reference materials for calibration traceability of medical laboratory measurement procedures. The Japanese Committee for Clinical Laboratory Standards and the National Metrology Institute of Japan developed both a pure substance C-peptide certified reference material and a reference measurement procedure that were listed by the JCTLM. Japan also organized a national program to standardize results of medical laboratory measurement procedures using pooled serum supplemented with C-peptide as reference materials. The International Bureau of Weights and Measures and the National Metrology Institute of China organized a key comparison among 10 national metrology institutes …