血清肌酸激酶活性检测的分析测量范围建立与评价

目的探讨应用上海科华试剂在日立7020生化仪上检测血清肌酸激酶（CK）活性的分析测量范围。方法参照临床和实验室标准化协会（CLSI）EP6-A文件要求,选用超过厂家声明的分析测量范围上限的高值血清标本（H）和低浓度的低值血清标本（L）,按比例配成等间距的10个不同浓度标本,每个标本重复测定2次。对所得数据应用SPSS19.0统计软件进行多项式回归分析。结果得到线性回归方程Y=397.442 X-1.211。其中b0=-1.211与0的差异无统计学意义（t=-0.175,P〉0.05）。肌酸激酶活性的分析测量范围是13.5～3 178.5U/L。结论应用科华试剂在日立7020生化仪上检测血清肌酸激酶活性可得到比较理想的分析测量范围,能够满足大部分精神疾病临床常规检测的需要。

Establishment and evaluation of the analytical measurement range of in the detection of serum Creatine Kinase

Objective To explore the analytical measurement range of the serum Creatine Kinase（CK）detected by Hitachi 7020 automatic analyzer with the ShangHai KeHua biochemistry reagent kits.Methods According to the EP6-A document published in 2004 by American Clinical and Laboratory Standards Institution（CLSI）,the ten samples with equal interval,proportional prepared with the low levels serum（L）and the high levels serum（H）exceeding the high limit claimed by manufacture were detected twice each.The results were registered and analyzed by the SPSS19.0 statistic software with polynomial regression analysis.Results The polynomial regression curve was：Y=397.442X-1.211.There was not significantly different between＂b0=-1.211＂and＂0＂,by t test（t=-0.175,P0.05）.The analytical measurement range of Creatine Kinase was 13.5-3 178.5 U/L.Conclusion Hitachi 7020 automatic analyzer with the KeHua biochemistry reagent kits has a good analytical measurement range,which can meet more needs of clinical routine for detecting CK of the mentlly ill persons.