运行IS015189质量体系过程中对临床生化测量结果不确定度评估的一些探讨

To Study the Measurement Uncertainty of Clinical Biochemistry Results in the Process of Running the ISO15189 Quality System of Our Department

目的初步探讨如何对临床检测结果进行不确定度评估，并比较两种方法间的优越性。方法按照GUM的要求，采用A，B类不确定度和两种不同的计算方法，评定实验室主要常规项目（TP，ALB，BUN，GLU）的测量不确定度，并对评定结果进行比较。结果以批内、批间和方法学偏倚为分量进行不确定度评估主要与室问质评的靶值相关。以长期重复性和校准品不确定度为分量进行评估两者都是构成不确定度的主要分量。结论采用A，B类评定方法，以长期重复性和校准品不确定度为分量进行评估更方便临床工作，为进一步研究提供一些思路和线索。

Objective To explore the measurement uncertainty of the clinical test results,and compare the superiority between the two methods. Methods According GUM,the measurement uncertainty of main routine was evaluation by using A and B of evaluation method,and compared the two types calculate methods. Results The uncertainties of routine biochemisity e- valuated by within,with-run and bisa. It was mainly related to the target value of the EQA. The uncertainties of routine bio- chemisity evaluated used long time CV and uncertainties of calibration,two both could cause the main component of the un- certainty. Conclusion The measurement uncertainty of main routine was evaluation by using A and B of evaluation method, to facilitate the clinical work. The uncertainties of routine biochemisity evaluated used long time CV and uncertainties of cali- bration was better. This method to provide some ideas and clues for further research.