Cooper G R, Myers G L
Division of Environmental Health Laboratory Sciences, Center for Environmental Health and Injury Control, U.S. Department of Health and Human Services Atlanta, Georgia 30333.
Scand J Clin Lab Invest Suppl. 1990;198:27-31.
A reference system for cholesterol measurement is necessary to assure accuracy of cholesterol measurements by clinical, research, and manufacturers' laboratories. Such a reference system is based on the collaboration of laboratory and clinical professionals, research groups, professional societies, government groups, and manufacturers of diagnostic products. Essential components include a definitive method, a reference method, and commutable reference materials that are accurately labeled and have long-term stability. A mechanism by which clinical, research, and manufacturers' laboratories can establish traceability to the reference system is also needed. In the United States, the NRS/CHOL was organized as part of the National Reference System for the Clinical Laboratory. The major organizational components of the NRS/CHOL include the National Institute for Standards and Technology, the CDC, the CRMN, the CAP, the AAB, regional reference programs, and manufacturers of cholesterol diagnostic products. The NIST maintains an isotope dilution-mass spectrometer definitive method and distributes certified reference materials. The CDC maintains a modified Abell-Levy-Brodie-Kendall reference method and offers a CDC-NHLBI Lipid Standardization Program; the CRMN provides reference method analyses on specimens furnished by manufacturers and clinical or research laboratories; CAP, AAB, and regional reference programs provide either proficiency testing, quality assurance programs, or both; and manufacturers assure that results on diagnostic products are the same as those achieved when using fresh patient specimens and the NRS/CHOL reference method. The NRS/CHOL has contributed much to the success of clinical epidemiologic and research and development investigations in coronary heart disease.
胆固醇测量的参考系统对于确保临床、研究及制造商实验室胆固醇测量的准确性至关重要。这样一个参考系统基于实验室和临床专业人员、研究小组、专业协会、政府团体以及诊断产品制造商之间的合作。其基本组成部分包括一种决定性方法、一种参考方法以及准确标记且具有长期稳定性的可互换参考物质。还需要一种临床、研究及制造商实验室能够建立与该参考系统溯源性的机制。在美国，NRS/CHOL作为临床实验室国家参考系统的一部分而组建。NRS/CHOL的主要组织构成包括国家标准与技术研究院、疾病控制与预防中心、临床参考物质中心、美国病理学家协会、美国分析生物学家协会、区域参考项目以及胆固醇诊断产品制造商。国家标准与技术研究院维持一种同位素稀释质谱仪决定性方法并分发经认证的参考物质。疾病控制与预防中心维持一种改良的阿贝尔 - 利维 - 布罗迪 - 肯德尔参考方法并提供疾病控制与预防中心 - 美国国立心肺血液研究所脂质标准化项目；临床参考物质中心对制造商以及临床或研究实验室提供的标本进行参考方法分析；美国病理学家协会、美国分析生物学家协会以及区域参考项目提供能力验证、质量保证项目或两者兼具；制造商确保诊断产品的结果与使用新鲜患者标本及NRS/CHOL参考方法时所获得的结果相同。NRS/CHOL对冠心病临床流行病学以及研发调查的成功贡献颇大。
