Schaffer R, Bowers G N, Melville R S
Organic Analytical Research Division, National Institute of Standards and Technology, Gaithersburg, MD 20899, USA.
Clin Chem. 1995 Sep;41(9):1306-12.
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.
1967年胆固醇作为标准参考物质（SRM）的发布，开启了美国国家标准与技术研究院（NIST；当时名为国家标准局）的一项重大工作，旨在帮助临床实验室建立并提高其测量质量。如今，NIST为此发布了三种SRM：作为一级标准的具有认证纯度的分析物样本、具有认证分析物浓度作为准确性控制的血清样本，以及经认证用于校准仪器的材料。在与临床实验室科学家合作建立测量分析物的参考方法（RM）时，NIST开发了用于评估RM准确性的权威方法（DM），然后使用DM为其SRM赋予分析物值。文中讨论了SRM和DM的开发情况。
