HISTORY OF NISTS CONTRIBUTIONS TO DEVELOPMENT OF STANDARD REFERENCE MATERIALS AND REFERENCE AND DEFINITIVE METHODS FOR CLINICAL-CHEMISTRY

The issuance of cholesterol as a Standard Reference Material (SRM) in 1967, started the National Institute of Standards and Technology (NIST ; then named the National Bureau of Standards) on a major effort to he lp clinical laboratories establish and improve the quality of measurem ents they make. NIST now issues three kinds of SRMs for that purpose: analyte samples of certified purity as primary standards, serum sample s having certified analyte concentrations as accuracy controls, and ma terials certified for calibrating instruments. In working with clinica l laboratory scientists to establish Reference Methods (RMs) for measu ring the analytes, NIST developed Definitive Methods (DMs) to use for evaluating RM accuracy and then used the DMs for assigning analyte val ues to its SRMs. The development of SRMs and DMs is discussed.