摘要
目的 应用美国临床和实验室标准研究所（CLSI）EP9-A2评价文件对两种碱性磷酸酶（ALP）试剂进行方法学比对分析,探讨两种试剂测定ALP是否具有可比性.方法 依据EP9-A2文件要求,每天随机从临床样本中抽取8份不同浓度水平的血清样本,分别用两种试剂进行ALP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某医学决定水平处的预期偏倚（BAK^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 不同试剂对ALP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 在实验室用两种以上试剂检测同一项目时,可参照EP9-A2文件进行方法学比对和偏倚分析,判断其临床可接受性能,以保证实验室检测结果的准确性和可比性.
Objective To investigate the Alkaline phosphatase（ALP）comparability between two kinds of analytic reagent systems by comparative analyzing ALP test results using CLSI EP9 - A2 document. Methods Based on the guideline of EP9 - A2, target seru - enzyme of eight different concentrations of samples involved randomly were measured by two types of ALP reagents for five days consecutively, and collect the results of five days together. All results were subjected to accumulate the linearity equation and the relativity coefficient. The 95 % confidence interval of Bc （bias at medical decision level X） were calculated to estimate acceptability of the bias. Results All of the bias of sero - enzyme results were accepted within the range of the allowable error by different types of analytic systems, and the results from two types of detection systems were comparable. Conclusion When the same test item is analyzed by over two detection systems, it is necessary, to evaluate the clinical acceptability to insure the accuracy and comparability by method comparison and bias estimation based on EP9 - A2 document.
出处
《医学检验与临床》
2010年第6期33-34,37,共3页
Medical Laboratory Science and Clinics
