电化学发光法与ELISA法检测甲胎蛋白的比较

目的对两种定量检测血清游离甲胎蛋白（AFP）的方法进行性能比较,探讨其检测结果的可靠性及实用价值。方法选择目前国内各级医疗单位中最常用的免疫学定量检测血清游离甲胎蛋白（AFP）方法,即电化学发光法和酶联免疫吸附试验（ELISA）法,各种方法均严格按照试剂盒要求操作进行检测。结果两种方法均能较准确的反映血清中游离AFP的含量,ELISA法与电化学发光法比较相关系数大于0.97,显示高度相关。二者经配对样本t检验比较,结果差异无统计学意义（P〉0.05）。两种方法比较的预期偏倚和相对偏倚都在可接受范围之内。结论 ELISA法与电化学法检测结果成直线相关,相关系数大于0.97。血清AFP浓度大于30μg/L时,预期偏倚和相对偏倚均在允许偏倚之内,结果可接受。而当AFP浓度小于20μg/L时,预期偏倚和相对偏倚均在允许偏倚之外,检测结果不能被接受。因此,两种检测方法在一定程度上可以替换使用。

Comparative Study on Results of Alpha-fetoprotein Test Between Chemiluminescence and ELISA Assay

Objective To compare the performance of quantitative detection of serum free alpha-fetoprotein(AFP) by chemiluminescence immumoassay and enzyme-linked immunosorbent assay(ELISA),and to explore the reliability and practical value of the two methods. Methods The two methods of quantitative detection of immunological AFP,chemiluminescence immumoassay and ELISA,which were most commonly used in all levels of medical institutions,were used in this study.The experimental operation was performed according to the requirements of the detection kits. Results The content of free AFP in serum was accurately reflected by the two methods.The linear correlation coefficient for ELISA vs chemiluminescence immumoassay was >0.97,which showed that there was a good correlation between them.The detection results of the two methods were compared by paired sample t-test,and no statistically significant difference was found between them(P>0.05).Data about comparison of the two methods showed expected bias and relative bias were both within the acceptable range.Conclusions There was a linear correlation between the detection results of the two methods,and the linear correlation coefficient was >0.97.The expected bias and relative bias were both within the acceptable range when the serum AFP level was >30 ug/L,while they were both beyond the acceptable range when the serum AFP level was < 20 ug/L.Therefore,the two methods can be exchanged to a certain extent in clinical detection.