光激化学发光法检测甲胎蛋白实验性能评价  

Analytical performance of light initiated chemiluminescence assay for serum α-fetoprotein

作　　者：高云朝[1] 赵卫国 

机构地区：[1]上海交通大学附属第六人民医院核医学科,上海200233 [2]博阳生物科技(上海)有限公司,上海201210

出　　处：《检验医学》2009年第8期578-581,共4页Laboratory Medicine

摘　　要：目的评价光激化学发光法(LICA)检测血清甲胎蛋白(AFP)的实验性能。方法利用定标品和质控品对LICA检测AFP的实验性能进行评价;利用358份含不同浓度AFP的血清标本对LICA和罗氏电化学发光免疫法进行方法学对比评价。结果LICA检测AFP的分析敏感性为0.25μg/L,在平均浓度10和500μg/L的检测总变异系数(CV)均<5%。与参比方法所测AFP浓度差异无统计学意义,2种方法所测结果的对数值呈直线相关(r=0.966,P<0.001),对标本阴、阳性分类差异无统计学意义(P=0.824),有较好的一致性(Kappa=0.886,P<0.001)。结论LICA检测AFP具有良好的检测性能;与罗氏电化学发光法具有类似的实验性能。Objective To evaluate the analytical performance of light initiated chemiluminescence assay （LICA） for serum α-fetoprotein （AFP）. Methods The analytical performance was evaluated with control and calibrator materials, and methodological comparison was carried out with electrochemiluminescence immunoassay using serum samples from 358 subjects with various concentration of serum AFP. Results The analytical sensitivity was 0.25 μg/L with total coefficient variation （CV） of 〈 5% measured at approximately 10 and 500 μg/L. The two methods had no significant difference in AFP eoncentrations with significant linear correlation （ r = 0. 966, P 〈 0. 001 ） for log transformed values, and also had no significant difference in sample classification （ P = 0. 824） with high consistency （Kappa = 0. 886, P 〈 0. 001 ）. Conclusions The LICA for AFP has very good analytical performance with diagnostic performance comparable with electrochemiluminescence immunoassay.

关 键 词：光激化学发光法 甲胎蛋白 电化学发光免疫法 

分 类 号：R446.61[医药卫生—诊断学]