亲和电泳酶免疫法快速测定AFP异质体

Rapid determination of alpha-fetoprotein heterogeneity by using affinity -electrophoresis enzyme immunoassay

目的建立 AFP异质体快速检测新方法 ,以促进其在临床上的普及。方法采用亲和电泳结合单克隆双抗体夹心酶免疫分析法。结果本法可在 6h内得出结果 ,灵敏度为 1ng/m L ,高、中、低浓度 AFP样本的结合型 AFP( AFP- h) ,平均CV为 5 .5 7%。临床应用表明 ,总 AFP及其异质体 ( AFP- h)诊断原发性肝癌 ( PHC)的敏感性分别为 73 .5 %和 90 .2 % ,特异性分别为 63 .5 %和 89.3 % ;准确度分别为 84 .6%和 94 .3 %。结论本法简便快速、使过去亲和交叉免疫电泳自显影法的 70 h缩短为 6h,而且灵敏度高 ,重复性好 ;AFP- h百分比与 AFP含量无关 ;AFP- h诊断 PHC的敏感性、特异性和准确度均优于AFP,并具有排除转移性肝癌和肝血管瘤的功能。

ObjectiveTo establish a new simple and rapid method of alpha-fetoprotein heterogeneity(AFP-h) assay and to popularize its clinical application.Methods By using an uncoloured affinity-electrophoresis combined with monoclonal double antibody sandwich enzyme immunoassay.ResultsMethodology evaluation showed that this method could report the results within 6 hours with a sensitivity up to 1 ng/mL,and an accuracy up to 5.57%. The diagnostic sensitivity, specificity and accuracy of AFP were 73.5%, 63.5% and 84.6%, respectively, while those of AFP-h were 90.2%, 89.3% and 94.3%, respectively. Conclusions This method is simple and rapid. We cut down the time required in affinity-crossed-immunoelectrophoresis autoradiography from 70 hours in the past to 6 hours by using this method.It is of very good repetition and sensitivity. AFP-h for diagnosis of primary hepatocarcinoma is better than AFP, and may exclude the false positives caused by secondary hepatocarcinoma and liver vascular tumor.