适用于BeckmanCX3全自动生化分析仪总蛋白试剂的研制与应用

Preparation and Application of Total Protein Agent for Beckman CX3 Automatic Biochemical Analyzer

目的 研制适用于Beckman CX3全自动生化分析仪总蛋白试剂的配置方法。方法 ①对不同组成成分的双缩脲试剂与蛋白质反应的动力学研究。②对自配试剂与Beckman公司生产的总蛋白试剂进行方法学评价和比较。结果 ①随酒石酸钾钠浓度增加反应速度加快,当达到一定浓度时反应速度不再增加,②随NaOH浓度增加反应速度先随之增加而后随之减低呈一个山峰状曲线。③将自配与进口试剂进行方法学评价比较,回收率分别为100.7％和99.2％;批内变异系数分别为0.78％和0.77％;批间变异系数分别为1.85％和3.00％;临床对照154例结果无显著性差异(t=1.67,P>0.05)。结论 自制的适用于Beckman CX3全自动生化分析仪总蛋白试剂完全可以取代同类进口产品。

Objective To prepare total protein agent for Beckman CX3 automatic biochemical analyzer. Methods (1)Study of reaction dynamics of different TP reagent and protein.(2)Evaluation and comparison of the methods of self-prepared-agent and Beckman's agent. Results (1)Reaction speed increased with the increase of concentration of potassium sodium tart ate; however, reaction speed did not increase any more when the concentration of potassium sodium tartate reached a certain degree. (2)With increase of NaOH concentration,reaction speed increased first and then decreased. (3)Comparison of methods self-prepared agent and imported agent showed that their recovery rates were 100. 7% and 99. 2% respectively; Variation coefficient within wholesale were 0. 78% and 0. 77% respectively; Variation coefficient among wholesale were 1. 85% and 3. 00% respectively. The result of clinical comparison of 154 samples showed no significant differences (t=1.67, P>0. 05). Conclusion Self-prepared total protein agent for Beckman CX3 automatic biochemical analyzer may substitute for imported agent of same kind.