免疫层析法作早孕快速诊断测定

Rapid diagnosis of early pregnancy using immunochromatography

为对免疫层析法在早孕诊断中的应用进行研究，以抗人绒毛膜促性腺激素（ｈＣＧ）α亚基的单克隆抗体制备免疫金溶胶，将该金溶胶与高度特异和亲和性强的抗ｈＣＧβ亚基单克隆抗体分别固定于条状硝酸纤维素膜的两个区域，制备了尿液ｈＣＧ快速测定试纸条。测定方法极为简便，特异性强，与２０００ＩＵ／Ｌ的黄体激素无交叉反应，检测敏感度达５０ＩＵ／Ｌ经５３８例临床标本测定，与进口的商品试纸条符合率为１００％。有可能发展成一种新的国产早孕诊断试剂。

The application of imrnunochromatography in the diagnosis of early pregnancy was studied.A test strip for the rapid detection of hunian chorionic gonadotrophin(hCG)has been prepared using a nitro- cellulose membrane which contained two zones where a monoclonal anti-α-hCG antibody marked by col- loidal gold and a monoclonal anti-β-hCG antibody with high specificity and avidity were fixed seperate- ly. The test is simple. No cross-reaction with luteinizing hormone(LH) indicates that the test is highly specific. The sensitivity of the test strip is about 5 0IU/L. Testing of 5 38 samples of woman urines shows that the strip results are completely coincident with the same products from abroad.It may be possibie that the strip developed is a new tool for the early pregnantic diagnosis in domestic hospitals.