安徽医科大学学报Issue(5)：625-627,3.
电化学发光法不同批号癌胚抗原试剂检测结果偏倚分析
Detection results of different batches of CEA reagent by electrochemiluminescence：A bias analysis
摘要
Abstract
Objective To investigate the effect of different batches reagent of carcino-embryonic antigen by the electrochemiluminescence on the patients when internal quality control has obvious bias. Methods We measured samples from two batches of CEA clinical specimen, 66 from batch 171617 and 58 from batch 172356. All of these samples were re-measured by batch 172356, and then the bias of the two measures was analyzed. Results The de-tection results in different batches of reagent were of statistical significance (P = 0. 012). In result bias, there was a significant difference between the two groups (P < 0. 001). In the ratio of the positive and negative bias, there was also a significant difference between the two groups (P < 0. 001). There was no statistical significance (P =0. 828) in different batches of reagent following the adjustment of patients′ outcomes according to the bias of inter-nal quality control. There was no statistical significance (P = 0. 092) either after the adjustment in different batches of reagent compared with that of the same batch of the reagent. The proportions of the positive and the negative bias were of no statistical significance (P = 0. 774) compared with those of the same batch of reagent. Conclusion The patients′ outcomes would produce similar bias when the target value of CEA internal quality control detected by dif-ferent batches of reagents has significant bias and this bias can be adjusted by an adjustment factor.关键词
电化学发光法/癌胚抗原/偏倚Key words
electrochemiluminescence immunoassay/carcinoma embryonic antigen/bias分类
医药卫生引用本文复制引用
李涛,刘亚婷,闫川,徐元宏,周敏,肖春红,郝丽..电化学发光法不同批号癌胚抗原试剂检测结果偏倚分析[J].安徽医科大学学报,2015,(5):625-627,3.基金项目
国家自然科学基金(编号:30801088、81201488) （编号:30801088、81201488）
卫生部应用研究项目“高通量 ELISA 检测系统化、标准化系列研究”(28-1-50) （28-1-50）
