酶联免疫吸附试验结果不确定度的动态评定

Dynamic evaluation of uncertainty of ELISA results

目的采用方程模型对酶联免疫吸附试验的不确定度进行动态评定,使其更具科学性、合理性和复现性。方法依据JJF1059-1999《测量不确定度评定与表示》,引入数学模型对ELISA法检测梅毒螺旋体抗体结果的不确定度进行评定。通过重复测定不同浓度样品获得检测数据,利用SPSS17.0统计软件对数据做拟合优度检验,确定拟合度最好的方程模型。结果评价影响检测结果的不确定度分量,对各个分量进行分析和量化,获得测量结果的不确定度,并作出科学表述。分析认为样本的不确定度在所有不确定度分量中占有绝对比重,三次方程模型是评定样本不确定度的最佳模型。结论样本的不确定度分量作为不确定度评定的重要分量,在绝大多数ELISA的不确定度评定中被忽略。不确定度的动态评定能有效解决ELISA试验中不确定度动态变化的问题。

Objective To carry out dynamic evaluation of the uncertainty of ELISA by equation model, in order to make it more scientific, reasonable and reproducible. Methods The uncertainty of ELISA in detection of treponema pallidum antibody was evaluated using mathematical model according to JJF1059 - 1999 ＂ Evaluation and expression of uncertainty measurement＂. Based on data from repeated determination of samples at different concentrations, goodness - of - fit test was obtained by SPSS17.0 statistical software to determine the best -fit equation model. Results The uncertainty components were evaluated through analysis and quantification of individual component to get the uncertainty of the measurement results with scientific de- scription. In all of the uncertainty components, sample uncertainty occupied the absolute dominant position, and the cubic equa- tion was the best model of sample uncertainty assessment. Conclusion Sample uncertainty as an important factor in uncertainty assessment is frequently ignored. Dynamic evaluation of uncertainty can deal with dynamic changes of the uncertainty in ELISA test.