对国产抗-HBs放免试剂的确证

用北京生物制品研究所出品之抗-HBs放免试剂检测抗-HBs,有时比Abbott同类试剂(Ausab)检出率高。为确证其是否真实,对11份二者检出不一致的血清用血源HBsAg及基因重组HBsAg作中和试验。均能中和。以正常人血清免疫小鼠所获抗血清则与该试剂未出现非特异反应。证明此试剂具有较高灵敏度与特异性。这与中国药品生物制品检定所检定该试剂灵敏度较高(一般为0.5～2.mIU/ml,Ausab一般为1～5mIU/ml)是一致的。

Specificity Confirmation Test of Local Made Anti-HBs RIA Kit

It was found that the anti-HBs detection rate of RIA kit manufactured by NIVSB (National Institute of Vaccine and Serum, Beijing) was sometimes higher than that of Ausab (Abbott RIA kit). Neutralization test with plasma derived HBsAg or DNA recombinated HBsAg had been done and both antigens blocked the positive reactions. Mouse sera anti-normal human serum did not react with RIA kit of NIVSB or others. All these results confirmed high specificity and sensitivity of this RIA kit, which was agreeabie with the sensitivity test result by NICPBP. The NIVSB's kit could detect anti-HBs at a level of 0.5～2 mIU/ml while Ausab 1～5 mIU/ml.