牛布鲁氏菌病阳性血清国家标准品的研制

Preparation and characterization of follwing the national standard anti-Brucella abortus serum, bovine

摘要:

为制备标定凝集试验用的牛布鲁氏菌病阳性血清国家标准品，采集4份田间自然感染牛布鲁氏菌病的阳性血清作为候选物，经过筛选后，选择了3#血清用于标准品制备。对该标准品进行了物理性状、无菌检验、真空度测定、剩余水分检验、均匀性检测和稳定性试验，检测结果均符合要求。以国际标准品为参比，测定了该标准品的RBT、SAT和CFT效价，结果分别为1∶160“+”、1∶2 400“++”、1∶800“++”，与协作标定结果完全一致。该标准品以国际标准品溯源的国际单位含量为4 000 IU/mL。

Abstract:

To prepare anti-Brucella abortus serum used for calibrate the agglutination test follwing the national standard, 4 anti-Brucella abortus sera were obtained from 4 cows infected with Brucella abortus naturally. By potency testing, the third serum was selected. Sterility, vaccum degree, residual moisture, uniformity and stability of this standard material were tested and proved to meet the national standard. Referring to the international standard, RBT (Rose-Bengal plate agglutination test), SAT (standard tube agglutination) and CFT (complement fixation test) titers of this standard material were measured to be 1:160 “+”, 1:2 400 “++” and 1:800 “++”, which are identical with the collaborative assay results. International unit of the standard material is 4 000 IU/mL.