铁蛋白免疫测定用标准品的研制及标定

  • 摘要: 铁蛋白原料经聚丙烯酰胺凝胶电泳分析未见杂质色带,蛋白定量分析为1.06g/L;用放射免疫分析方法标定其免疫活性为1.015g/L,其剂量-反应曲线与人铁蛋白第二次国际标准品(编号80/578)平行,表明该原料适于制作标准品。用含1%人血清白蛋白的磷酸盐缓冲液配制的1.25mg铁蛋白原料按每安瓶2μg分装,经冷冻干燥制备成标准品。以铁蛋白国际标准品为对照品,用放射免疫分析法对其免疫活性进行标定,均值为1.962μg/支。分别以国际标准品和本标准品为对照品测定同一套铁蛋白质控血清,证明对不同浓度水平的质控血清测定均值非常接近,且在统计学上无显著差异

     

    Abstract: PREPARATION OF FERRITIN NATIONAL STANDARDShen Hongzheng Jiao Yan Xu Ligen(China National Institute of Control for Pharmaceutical and Biological Products, Beijing 100050) ABSTRACTThe raw material of ferritin is analyzed for preparation of ferritin national standard (NS) for immunoassay. No impure zone is found by polyacrylamide gel electrophoresis. The protein amount is 1.06 g/L and the immunoactivity is 1.015 g/L by RIA, with its doseresponse curve being parallel to that of Human Ferritin 2nd International Standard coded 80/578(IS). This shows that the material used is suitable for preparation of ferritin NS. 1.25 mg of raw material diluted in 0.01 mol/L phosphate buffer solution (pH7.4) containing 1% human serum albumin is distributed into aliquot of 0.8 mL(2 μg per ampoule),lyophilized and assayed by RIA. The mean value of this NS is 1.962 μg per ampoule in terms of IS. Similar values are obtained for the ferritin contents of quality control serum samples at different content levels when either IS or NS is used as the assay calibrator. This indicates that there is no statistically significant diference between the serum sample values at the same levels.Key words ferritin international standard national standard radioimmunoassay calibration

     

/

返回文章
返回