Park Joonseok, Chun Sail, Kim Jin-Q, Song Junghan, Kim Jae-Joong, Min Won-Ki
University of Ulsan College of Medicine, Seoul, Korea.
Ann Clin Lab Sci. 2010 Winter;40(1):53-60.
It is recommended that clinical laboratories keep the bias of serum total cholesterol analysis at < or =3.0% compared to a reference method. In Korea, national cholesterol proficiency testing has long been available, but there has been little information about the magnitude of analytical bias. The authors calculated the bias of the peer group mean for Korea's national cholesterol proficiency test through an indirect approach that overcomes the potential matrix effect of proficiency test materials. One laboratory was selected among the proficiency test participants to represent Korean laboratories. Total cholesterol levels of six fresh serums spanning a wide range of concentrations were measured by the representative laboratory and three reference laboratories. The relationship between the proficiency test mean and the reference method mean was established by linear regression analysis. The peer group mean of the proficiency test was calculated to have a bias of +2.4 to +2.5% at the medical decision levels. When grouped by instrument and reagent, 29 to 66% of the laboratories showed biases <3.0%. Thus it was determined that the peer group mean of the Korean cholesterol proficiency test has an acceptable level of positive bias. The indirect approach used in this study provides a practical model for estimating cholesterol analytical bias for proficiency testing.
建议临床实验室将血清总胆固醇分析的偏差控制在与参考方法相比≤3.0%。在韩国，国家胆固醇能力验证长期以来一直存在，但关于分析偏差程度的信息很少。作者通过一种间接方法计算了韩国国家胆固醇能力验证中同组均值的偏差，该方法克服了能力验证材料潜在的基质效应。从能力验证参与者中选择一个实验室来代表韩国实验室。由该代表实验室和三个参考实验室测量了六种浓度范围广泛的新鲜血清的总胆固醇水平。通过线性回归分析建立了能力验证均值与参考方法均值之间的关系。计算得出，在医学决定水平上，能力验证的同组均值偏差为+2.4%至+2.5%。按仪器和试剂分组时，29%至66%的实验室偏差<3.0%。因此确定韩国胆固醇能力验证的同组均值具有可接受水平的正偏差。本研究中使用的间接方法为估计能力验证中的胆固醇分析偏差提供了一个实用模型。
