沙门菌马流产凝集试验阳性血清国家参考品的制备及标定

Preparation and calibration of positive sera national reference for salmonella abortus-equi for agglutination test

为研制沙门菌马流产凝集试验阳性血清国家参考品,以提高沙门菌马流产凝集试验抗原国家参考品、抗原及阳性血清国家参考品、阳性血清的半成品和成品检验的可靠性和可重复性,本研究按照沙门菌马流产凝集试验阳性血清制备的现行标准及标准物质研究的相关规定,规范了沙门菌马流产凝集试验阳性血清参考品的制备及检定方法。用沙门菌马流产凝集试验抗原国家参考品测定阳性血清效价,将血清稀释至1∶1600、1∶3200、1∶6400,分别准确定量分装后,按照特定的冻干曲线冻干,分别用抗原国家参考品测定冻干血清的效价,测定3种效价血清的均一性和稳定性,将阳性血清国家参考品应用于生产检验。结果表明,该参考品均一性良好,在有效期内效价稳定,可以作为国家参考用品应用。

The positive serum national reference for salmonella abortus-equi agglutination test was developed according to the previous standards and some standards related to reference materials in order to improve the dependability and repeatability of the test results of national reference antigen for salmonella abortus-equi,antigen,positive sera national reference,positive sera and negative sera.This study specified the development and test methods of positive serum national reference.We first tested the agglutination titer and then diluted the sera to the titer of 1∶1 600,1∶3 200,1∶6 400.Then,we packaged the same content to the ampoule bottles,then dry-froze them according to a special freeze drying curve.We tested the agglutination titer with the national reference antigen and the uniformity and stability of the sera with different titers separately.The results showed that there was a good uniformity and stability in the application of the positive serum reference in the production and the test process of salmonella abortus-equi positive sera,salmonella abortus-equi antigen and their references,indicating that the product can be used as a national reference material.