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酶法测定血清钾离子试剂改进及评估
引用本文:王永超,肖禄生,王缦,.酶法测定血清钾离子试剂改进及评估[J].中国医学工程,2013(11):11-12,14.
作者姓名:王永超  肖禄生  王缦  
作者单位:[1]华东理工大学生物化学与分子生物学系,上海200237 [2]上海科华生物工程股份有限公司,上海200133
摘    要:目的建立一种酶法测定血清钾离子液体试剂的方法,并评估该液体试剂的重复性(批内精密度)、抗干扰能力、线性、热稳定性,与离子选择电极法fISE)的相关性。方法对原有酶法测定血清钾离子方法进行了改进,并参考临床和实验室标准协会(CLSI)相关文件对试剂进行评估。结果批内精密度0.846%~1.338%;线性范围0.~10mnl01/L(γ=0.999);干扰物浓度总胆红素(TBil)600mg/L,直接胆红素(DBil)600.mg/L,维生素C(Vc)60.0.mg/L,乳糜15mg/L,血红蛋白10g/L时对试剂干扰不明显(≤±10%),抗钠离子干扰为249;该液体试剂与ISE法的回归方程Y=1.0345X+0.0753,相关系数1为0.984(P〈0.001),显著相关;试剂热稳定性在37℃下放置7d后初始吸光度值降低15.43%。结论试剂改良后线性、批内精密度、抗干扰能力、热稳定性、与ISE显著相关。

关 键 词:酶法测定  血清钾  冻干试剂  液体试剂

The improvement and assessment for method of enzymatic determination of potassium in serum
WANG Yong-chao,XIAO Lu-sheng,WANG Man.The improvement and assessment for method of enzymatic determination of potassium in serum[J].China Medical Engineering,2013(11):11-12,14.
Authors:WANG Yong-chao  XIAO Lu-sheng  WANG Man
Institution:1 East China University of Science and Technology, Shanghai 200237; 2.Shanghai Kehua Biological Engineering Stock Company, Shanghai 200133 )
Abstract: Objective ] hnproving the method of determination of potassium in serum which used to be freeze-dry powder powder.Testing the repeatability(within run precision),interference,linearity, stability of the new method. Made the comparison test with ISE. Methods ] We Improved the enzymic method evaluated the new method according to the CLSI documents. Resluts ] Repeatability: CV between 0.846%-1.338%;the linearity range( 0-10 retool/L), γ =0.999;No significant interference of the new method was found when total bilirubin 600 mg/L, direct bilirubin 600 mg/L, vitamin C 600 mg/L,turbidity 15mg/L,hemoglobin 10 g/L; Compare with ISE method,Y= 1.0345 X+0.0753, γ =0.984(P〈0.001);Thermo-stability:the initial ABS decreased 15.43% compare with the control which is stored at 2 ℃ -8 ℃2 . Conclusion ] Compare with the freeze-dry powder reagent,the new reagent's linearity,repeatability,stability are acceptable,and significant correlation with ISE method.
Keywords:method of enzymatic determination  potassium in serum  freeze-dry powder  liquid reagent
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