两种商品定量试剂盒分析性能的验证试验

The verification of analytical performance of two commodities quantitative kits

目的验证甲胎蛋白(AFP)、癌胚抗原(CEA)商品定量试剂盒的分析性能。方法根据"中华人民共和国卫生行业标准WS/T xxx-2008"的要求,对AFP、CEA商品定量试剂盒分析性能进行验证。结果 AFP、CEA定量试剂盒的批内、批间精密度CV值均小于厂家声称的相应CV值;正确度试验结果的平均偏倚值均低于厂家声称的偏倚值;各项目的测量区间验证值结果与预测值接近,相关系数(r)>0.975,线性理想(斜率b接近1)。结论本研究所验证AFP、CEA定量试剂盒的精密度、正确度和线性范围3个方面均达到了临床应用的实验要求。

Objective To verify the main analytical performance of AFP,CEA kits. Methods According to Health Industry Standards of People＇s Republic of China WS/T xxx-2008, we performed the verification test of AFP, CEA commodities quantitative kits. Results The results of within-run CV and between-run CV in the precision veri- fication experiments by using quality control serums were both lower than the corresponding CV values, which were manufacturers claimed. The average values of bias for trueness of verification experiments results were under the manufacturers claimed bias. The measuring interval of each testing items were close to the expected values. Coefficient of correlations（r）〉0. 975 and ideal linear （slope b was close to 1）. Conclusion The results of verification test showed that the precision, trueness and measuring interval involved in this study were all met the requirements of clinical application.