Clinical Chemistry
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Clinical Chemistry 41: 1306-1312, 1995;
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Clinical Chemistry, Vol 41, 1306-1312, Copyright © 1995 by American Association for Clinical Chemistry

History of NIST's contributions to development of standard reference materials and reference and definitive methods for clinical chemistry

R Schaffer, GN Bowers Jr and RS Melville
Organic Analytical Research Division, National Institute of Standards and Technology, Gaithersburg, MD 20899, USA.

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 help clinical laboratories establish and improve the quality of measurements they make. NIST now issues three kinds of SRMs for that purpose: analyte samples of certified purity as primary standards, serum samples having certified analyte concentrations as accuracy controls, and materials certified for calibrating instruments. In working with clinical laboratory scientists to establish Reference Methods (RMs) for measuring the analytes, NIST developed Definitive Methods (DMs) to use for evaluating RM accuracy and then used the DMs for assigning analyte values to its SRMs. The development of SRMs and DMs is discussed.


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