【摘要】 本文报导混合浓缩人血清工作标准(89-1)的制备和用WHO相应参考标准血清标定出其中五类免疫球蛋白(Igs)及IgG4亚类含量。该制剂主要用于体外测定IgG、IgA、IgM的工作标准,也可供作体外测定IgD、IgE、IgG4的工作标准。混合前每份血清均无乙型肝炎表面抗原、转氨酶正常。定量分装为每安瓿0.5ml,经冷冻干燥后,4℃保存。参照国际参考标准血清67/97及67/37,分别以免疫单扩散法标定89-1中IgG、IgA、ISM含量;以酶联免疫吸附试验(ELISA)标定IgD、IgG4和IgE含量。其中IgG、IgG4、IgA、IgM含量,应用本室制备的相应单克隆抗体(McAb)标定,而IgD和IgE应用多克隆抗体(PcAb)进行标定。并用五剂量法及四剂量法分别计算Igs含量。更多还原

【Abstract】 Normal human sera were collected, concentrated and calibrated with WHO International Reference Preparation of 5 classes immunoglobulins and subclass IgG4. The serum pool has been subaliquoted(0.5ml/ampule), lyphilized and stored at 4 ℃. The total IgG, IgA and IgM contents were calibrated with WHO International Reference preparation 67/97 by single radial immunodiffusion, using the corresponding monoclonal antibodies prepared in our laboratory. The total IgG, IgA and IgM contents are 345 IU/ml (27.74mg/ml), 321 IU/ml (4.56mg/ml)and 312 IU/ml (2.64mg/ml) respectively. The total IgG4 content was calibrated with the same Reference Preparation and corresponding monoclonal antibody by ELISA technique. The total IgG4 content is 0.66 mg/ml. The total IgD content was calibrated with WHO International Reference Preparation 67/87 by ELISA. It contains 74 IU/ml (104 μg/ml). The total IgE content was calibrated with working standard (code 89-1) by ELISA. The total IgE content is 604 IU/ml (1450 ng/ml). This working standard (Code 89-1) which is free from hepatitis Bsurface antigen is used mainly to determine IgG, IgA and IgM and also for IgD, IgE and IgG4.更多还原