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目的:比较甲胎蛋白(AFP)和癌胚抗原(CEA)的化学发光分析(IM)与放射免疫分析(RIA)的优缺点。资料和方法:正常对照 40例,病人标本 110例。分别用 RIA、IM(DPC公司的 Im-mulite)测定了 AFP、CEA。以回收率,批间、批内变异,非特异性结合率表示各方法的准确度、精密度、特异性等性能指标,方法学比较采用直线回归方程。结果:AFP、CEA RIA、IM 回收率均在95％～105％这间,批间批内变异均小于10％,非特异性结合率小于5％、1％,灵敏度为2.0ng/ml、0.2ng/ml。AFP RIA与 IM的直线回归方程为 Y_(RIA)=1.2766X_(IM)+2.6538。CEA RIA 与 IM的直线回归方程为 Y_(RIA)=1.2271X_(IM)+3.7245。结论:结果显示 AFP、CEA的 RIA与 IM的试剂盒质量较好,测量结果可靠,重复性好。IM 的准确度、精密度、特异性、灵敏度更优于RIA。AFP、CEA RIA 与IM两方法测量结果差异明显(P<0.05)。
OBJECTIVE: To compare the advantages and disadvantages of chemiluminescence (IM) and radioimmunoassay (RIA) of alpha fetoprotein (AFP) and carcinoembryonic antigen (CEA). Materials and Methods: Normal control in 40 cases, 110 cases of patient specimens. AFP and CEA were measured with RIA, IM (Im-mulite by DPC). The performance indexes such as accuracy, precision and specificity of each method were expressed in terms of recovery rate, inter-batch variation, intra-assay variation and nonspecific binding rate. The linear regression equations were compared with the methodologies. Results: The recoveries of AFP, CEA RIA and IM were in the range of 95% -105%. The intra-assay variation was less than 10%, the nonspecific binding rate was less than 5%, 1%, the sensitivity was 2.0ng / ml, 0.2ng / ml. The linear regression equation between AFP RIA and IM is Y RIA = 1.2766X IM +2.6538. The linear regression equation between CEA RIA and IM is Y RIA = 1.2271X IM +3.7245. Conclusion: The results showed that the quality of RIA and IM kit of AFP and CEA is good, the result is reliable and the repeatability is good. The accuracy, precision, specificity and sensitivity of IM are better than RIA. The results of AFP, CEA RIA and IM were significantly different (P <0.05).