全自动蛋白分析仪BN-100缓冲液、稀释液国产化研究

目的 实现全自动特种蛋白分析仪试剂国产化。方法 对原装试剂进行理化分析，择最佳配方，采用进口和自行研制的缓冲液、稀释液（自研试剂），在同样条件下按仪器操作规程于BN-100全自动免疫分析仪上对正常人标本、患者标本、原装质控物进行对比测定。结果 自研试剂的理化指标（pH、电导率及渗透压）与进口试剂相近；对德灵原装高、中、低值质控物，分别用进口试剂和自研试剂进行测定，其相关系数r均〉0．98；患者标本的相关性：IgG的相关方程y=1．0374x-0．28，r=0．998，IgA为Y=1．0111x-0．0594，r=0．989，IgM为Y=0．987x-0．0404，r=0．987；复性测定结果IgG、IgA、IgM结果自由度（v）均〈3％。结论 自研试剂可代替原机进口试剂在全自动蛋白分析仪上进行IgG、IgA、IgM检测。

Study of homemade solution and dilution buffers of automatic immunanalyzer for special protein

Objective:To study the value of the home made buffers solution and dilution of automatic immunanalyzer for special protein.Methods:Sample of protein were analyzed by automatic immunanalyzer under the same condition with imported and self-made sloutin and dilution respectively.Results:There were no difference in PH,ratio electrical conductive and smostic pressure examined by imported reagent and self-made reagent;The relativity is over than 0.98 between imported reagent and self-made reagent under high,middle and low original control reagent.The IgG relative equation is y=1.0374x-0.28,r=0.998,IgA equation is y=(1.0111x)-0.0594,r=0.989,IgM equation is y=0.987x-0.0404,r=0.987,the repeated v results of IgG,IgA,IgM are the less than 3%.Conclusion:The self-made buffer solution and dilution can replace imported reagent in the automatic analysis of protein.