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目的制备弓形虫IgG抗体检测试剂用血清国家参考品。方法收集弓形虫IgG抗体阳性血清和正常人血清,用6个厂家的弓形虫IgG检测试剂盒进行筛选,并采用染色试验和凝集试验予以确证,采用弓形虫IgG抗体国际标准品对阳性血清进行标定。参考品经协作标定,确定最低检出量标准。结果确定此套血清国家参考品共24份,其中阳性参考品9份(包括最低检出量参考品1份),阴性参考品15份。结论制备了第1套弓形虫IgG抗体检测试剂用血清国家参考品,并建立了相应的质量标准,已被国家有关部门批准正式使用。
Objective To prepare the national reference material of serum of Toxoplasma gondii IgG antibody detection reagent. Methods Toxoplasma gondii IgG positive serum and normal human serum were collected and screened by 6 Toxoplasma gondii IgG detection kits. The positive serum was screened by the staining test and agglutination test. The positive serum was calibrated with the international standard of Toxoplasma IgG antibody . Reference calibration by collaboration to determine the minimum amount of detection standards. The results of this set of serum national reference a total of 24, of which 9 positive reference (including the lowest detection reference 1, negative reference 15. Conclusion The first set of national standard reference materials for the detection of Toxoplasma gondii IgG antibody was prepared and the corresponding quality standards were established, which have been approved for formal use by the relevant state departments.