Bennett S T, Eckfeldt J H, Belcher J D, Connelly D P
Department of Laboratory Medicine and Pathology, UMHC, Minneapolis.
Clin Chem. 1992 May;38(5):651-7.
The National Reference Method Laboratory Network has initiated a program to certify clinical laboratory cholesterol measurement performance by using routine clinical specimens. Clinical laboratory and reference laboratory measurements of split samples are used to assess whether the clinical laboratory is meeting the Laboratory Standardization Panel's goals for accuracy and precision. We used a computer-based Monte Carlo simulation model of split-sample proficiency testing to evaluate the certification program and, in particular, to analyze the effects of reference laboratory bias and imprecision. Results of our simulations indicate that the accuracy of the certification program is strongly influenced by reference laboratory bias and less influenced by reference laboratory imprecision. The certification program is potentially highly accurate, but unless reference laboratory bias is tightly controlled, the number of classification errors may limit its utility. Moreover, the decision limit of the certification program needs to be higher than the Laboratory Standardization Panel's goal (3.5% instead of 3.0%) to ensure that an acceptably high proportion of well-performing clinical laboratories can become certified.
国家参考方法实验室网络已启动一项计划，通过使用常规临床标本对临床实验室胆固醇测量性能进行认证。临床实验室和参考实验室对分割样本的测量用于评估临床实验室是否达到实验室标准化小组在准确性和精密度方面的目标。我们使用基于计算机的分割样本能力验证测试的蒙特卡洛模拟模型来评估认证计划，特别是分析参考实验室偏差和不精密度的影响。我们的模拟结果表明，认证计划的准确性受参考实验室偏差的影响很大，而受参考实验室不精密度的影响较小。该认证计划可能具有很高的准确性，但除非严格控制参考实验室偏差，否则分类错误的数量可能会限制其效用。此外，认证计划的决策限需要高于实验室标准化小组的目标（3.5%而不是3.0%），以确保有足够高比例的表现良好的临床实验室能够获得认证。
