Fallest-Strobl P C, Olafsdottir E, Wiebe D A, Westgard J O
Department of Pathology and Laboratory Medicine, University of Wisconsin Medical School, Madison 53792, USA.
Clin Chem. 1997 Nov;43(11):2164-8.
The National Cholesterol Education Program (NCEP) performance specifications for methods that measure triglycerides, HDL-cholesterol, and LDL-cholesterol have been evaluated by deriving operating specifications from the NCEP analytical total error requirements and the clinical requirements for interpretation of the tests. We determined the maximum imprecision and inaccuracy that would be allowable to control routine methods with commonly used single and multirule quality-control procedures having 2 and 4 control measurements per run, and then compared these estimates with the NCEP guidelines. The NCEP imprecision specifications meet the operating imprecision necessary to assure meeting the NCEP clinical quality requirements for triglycerides and HDL-cholesterol but not for LDL-cholesterol. More importantly, the NCEP imprecision specifications are not adequate to assure meeting the NCEP analytical total error requirements for any of these three tests. Our findings indicate that the NCEP recommendations fail to adequately consider the quality-control requirements necessary to detect medically important systematic errors.
通过从美国国家胆固醇教育计划（NCEP）的分析总误差要求和检测结果解释的临床要求中推导操作规范，对测量甘油三酯、高密度脂蛋白胆固醇（HDL-胆固醇）和低密度脂蛋白胆固醇（LDL-胆固醇）的方法的NCEP性能规范进行了评估。我们确定了使用每次运行有2次和4次对照测量的常用单规则和多规则质量控制程序来控制常规方法时允许的最大不精密度和不准确性，然后将这些估计值与NCEP指南进行比较。NCEP的不精密度规范满足了确保达到NCEP对甘油三酯和HDL-胆固醇的临床质量要求所需的操作不精密度，但不满足对LDL-胆固醇的要求。更重要的是，NCEP的不精密度规范不足以确保达到这三项检测中任何一项的NCEP分析总误差要求。我们的研究结果表明，NCEP的建议未能充分考虑检测具有医学重要性的系统误差所需的质量控制要求。
