化学发光法检测血清甲胎蛋白的方法学评价

Methodological evaluation of chemiluminescent immunoassay for serum AFP

目的对化学发光免疫分析法（CUA）测定甲胎蛋白（AFP）进行方法学评价。方法用CLIA测定178例血清的AFP值，同时也用酶联免疫吸附试验（ELISA）对AFP进行测定。结果CLIA测定AFP的灵敏度为1．3ng／mL，低、中、高浓度的批内CV分别为4．2％、2．3％、1．6％；批间CV分别为4．8％、3．2％、2．5％。回收率为96％～104％，理论值与实测值的回归方程为Y=0．1427＋0．9992X，相关系数r=0．9900（P〈0．001）。ROC曲线显示CLIA测定的敏感性和特异性均在90％以上，曲线下面积为0．992，显著高于ELISA法（P〈0．01）。结论CLIA是目前测定AFP较好的方法，适用于临床对AFP进行检测，可对原发性肝癌进行明确诊断。

Objective To analyze the methodology of serum alpha fetoprotein （AFP） assay by chemiluminescent immunoassay （CLIA） and appraise its clinical value. Methods The semi-automatic CLIA analyzer and ELISA were employed to measure serum AFP in 178 patients with hepatocellular carcinoma （HCC）. Results The sensitivity of CLIA for AFP was 1. 3 ng/ml. The intra-batch CV of different concentrations （low, medium and high） was 4.2 % ,2.3 % and 1.6 % respectively, while inter-batch CV of different concentrations was 4.8%, 3.2% and 2.5% respectively. The recovery rate was 96%-104%. The linear regression equation between expected values and measured values was as follows：Y=0. 1427＋0. 999 2X and the correlation coefficient （r） was 0. 990 0 （P〈0. 001）. The ROC curve showed that both sensitivity and specificity of the CLIA surpassed 90%. The area under the curve was 0. 992,significantly higher than that of ELISA （P〈0. 01）. Conclusion CLIA is an excellent detection method for AFP at present,and may be applied to the definitely diagnosis of primary hepatic carcinoma.