全自动蛋白分析仪BN-100缓冲液、稀释液国产化研究

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

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。

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. 987 x-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.