ELISA检测血清CEA的测量不确定度评定的探讨

RESEARCH ON EVALUATION OF UNCERTAINTY IN MEASUREMENT OF ELISA DETECTING CEA

[目的]探讨医学实验室对ELISA的测量不确定度的评定方法。[方法]用ELISA测定3份血清中不同浓度的癌胚抗原并作批内重复,根椐直线回归方程建立数学模型,分析不确定度来源并计算各分量标准不确定度、合成标准不确定度、扩展不确定度。[结果]ELISA测定3份血清中癌胚抗原的测量不确定度分别为±1.58ng/ml、±5.90ng/ml、±9.75ng/ml(包含因子k=2.101)。[结论]包含有测量不确定度的结果更能反应测量的真实水平,但医学实验不确定度的评定方法还应深入探索。

[Objective] To study on evaluation of the uncertainty in measurement of ELISA in medical laboratory.Methods The CEA of 3 samples of serum were detected by ELISA and in-repeatabition,setting up a mathematical model in accordance with linear regression equation.Analyzed the source of the uncertainty and calculated the standard uncertainty of each portion、 the combined standard uncertainty and the expanded uncertainty.Results The uncertainty in measurement of ELISA detecting CEA of 3 samples were as follows：±1.58ng/ml,±5.90ng/ml,±9.75 ng/ml（the coverage factor K= 2.101）.Conclusion The result of containing the uncertainty can better reflect the real level of test,however,there’s still a long way to study the evaluation of the uncertainty in measurement of medical laboratory.