不同检测系统胆固醇、三酰甘油的偏倚分析

Analysis on the biases of assaying serum cholesterol and triglyceride by different kinds of detection system

目的通过不同检测系统的方法学比对分析,探讨各检测系统之间测定血清胆固醇、三酰甘油是否具有可比性。方法依据美国临床和实验室标准化研究所(CLSI)EP9-A2文件要求,每天随机从临床样本中抽取8份不同浓度的血清样本,分别用两种检测系统进行胆固醇、三酰甘油的测定,共测定5d,记录实验结果,将结果进行相关回归分析,计算在医学决定水平处的预期偏倚(B^c)和预期偏倚的95%可信区间,并判断偏倚是否可以接受。结果不同检测系统对胆固醇、三酰甘油测定结果的偏倚在允许误差范围内,两者结果具有可比性。结论当用两个以上的检测系统检测同一检验项目时,应进行方法比对和偏倚评估,判断其临床可接受性能,以保证检验结果的可比性。

Objective To investigate the comparability of the different kinds of detection system in measuring serum cholesterol and triglyceride and compare the two analysis systems. Methods Based on the guideline of CLSIEP9-A2,involved serum cholesterol and triglyceride were measured randomly from 8 serum samples with different concentration by the two types of detection system for five days, and the results were recorded at the same time. All of the results were subjected to accumulate the relativity coefficient. The 95% confidence interval of Bc （bias at medical decision level X） were calculated to estimate acceptability of the bias. Results The results of all the bias of serum cholesterol and triglyceride results were accepted within the range of the allowable error by different types of analytic systems, and the results gained from the two types of detection systems were comparable. Conclusion When the same test item is analyzed by the two detection systems,it is necessary to evaluate the clinical acceptability to insure the reliablity of the results.