商品化线性品在生化项目线性范围验证中的应用

Application study of commercial linear material in the linear range verification

目的 为保证本实验室生化检验结果的准确性和可靠性,通过应用商品化线性品对试剂厂商声明的线性范围进行验证,并探讨验证中出现非线性的原因。 方法 参照美国临床实验室标准化委员会(Clinical and Laboratory Standards Institute,CLSI)的EP06-A 文件,对总蛋白(TP)、白蛋白(ALB)、谷丙转氨酶(ALT)、谷草转氨酶(AST)、碱性磷酸酶(ALP)、尿素(BUN)、总胆固醇(CHO)、甘油三酯(TG)、葡萄糖(GLU)、高密度脂蛋白(HDL)、低密度脂蛋白(LDL)、无机磷(IP)、钙(Ca 2+ )、镁(Mg 2+ )、钾(K +)、钠(Na +)、氯(Cl -)17个生化检验项目的线性范围进行验证。 结果 17个生化检验项目线性范围均成一阶线性验证通过。 结论 商品化线性品在线性范围验证中有很好的使用效果,不仅验证了厂商的线性范围是否满足质量目标和临床检验的要求,同时在一定程度上避免了直接使用人血清引起的生物安全危害。

Objective To ensure the accuracy and reliability of the results of laboratory biochemical test,we validate the linear range of the reagent statement by applying the commoditized linear product,and analyze the reasons of nonlinear situation.Methods According to EP06-A files of the CLSI,we evaluated the performance of linear range of17biochemical test items,including TP,ALB,ALT,AST,ALP,BUN,CHO,TG,GLU,HDL,LDL,IP,Ca2+,Mg2+,K+,Na+and Cl-.Results The linear range of the seventeen biochemical test projects were first-order linear validation.Conclusion In the linear range verification,linear product commercialization has a good use effect,not only verify the linear scope of manufacturers whether meet the requirements of quality goals and clinical inspection,at the same time,to avoid biological safety hazards caused by serum at a certain extent.