CLSI-EP9-A2标准在两种不同尿素试剂间的应用

目的 通过对两种不同尿素试剂进行方法学比对分析,探讨各试剂测定血清尿素是否具有可比性.方法 依据美国临床和实验室标准研究所（CLSI）EP9-A2文件要求,每天随机从临床样本中抽取8份不同尿素浓度的血清样本,分别用两种试剂进行尿素的测定,共测定5天,记录检测结果,将结果进行相关回归分析.根据直线方程计算在医学决定水平处的预期偏倚（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 两种试剂对血清尿素测定结果的相关系数（r）=0.998,截距（a）=0.048,斜率（b）=0.987,回归方程：Y=0.987X＋0.048.无方法内、间的离群点,两者结果具有可比性.结论 当用两种或两种以上以上试剂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.

The application of CLSI-EP9-A2 standards in two kinds urea reagents

Objective To investigate the sero - Urea comparability between two kinds of reagents by comparative analyzing Urea test resuhs. Methods According to the guideline of CLSI - EP9 - A2, involved sero - Urea were measured from eight serum samples with different concentration randomly by two types of detection system for five days consecutively and record the results. All results were subjected to accumulate the linearity equation and the relativity coefficient. The 95% eontldence interval of Bc （bias at medical decision level X） were calculated to estimate acceptability of the bias. Results The correlation coefficient of using two kinds of Urea reagents was 0. 998, intercept （a） ：0. 048, slope（b） ： 0.987, regression equation ： Y = 0.987X ＋ 0.048, without outlier of within - method and between - method, and the results from two types of detection systems were comparable. Conclusion When the same test item is analyzed by two or more detection systenrs, it is necessary to evaluate the clinical acceptability to insure the comparability by method comparison and bias estimation.