【摘要】 目的验证罗氏尿镁试剂盒在日立7180生化分析仪上检测的线性范围。方法根据美国临床和实验室标准化协会(CLSI)制定的EP6-A2文件,选用高值标本(H)和低值标本(L)按比例配成等间距的6个不同浓度标本,在日立7180全自动生化分析仪上进行检测,每个标本重复测定2次,所得数据应用SPSS19.0统计软件进行多项式回归分析。结果样本重复测定比例误差(CVr)为1.48%,小于试剂盒说明书的批内不精密度要求3.00%。二次回归多项式非线性系数b2(t=-3.958,P=0.029)与0之间差异有统计学意义,三次回归多项式非线性系数b3(t=-2.448,P=0.134)与0之间差异无统计学意义,二次回归多项式为最适多项式。线性偏倚分析显示第一浓度点的线性偏倚(DLi)为-498.00%,大于设定目标5.00%。剔除第一浓度点,对剩余数据进行多项式回归分析,二次回归多项式的非线性系数b2(t=-3.113,P=0.090),三次回归多项式的非线性系数b2(t=2.708,P=0.225)、b3(t=-3.656,P=0.170)与0差异无统计学意义,一次回归多项式为最适多项式。多项式回归修正后的DLi≤5.00%。结论罗氏尿镁试剂盒在日立7180生化分析仪上检测的线性范围为3.4750~16.8850mmol/L,与试剂盒申明的线性范围基本一致,能够满足临床常规检测要求。更多还原

【Abstract】 Objective To validate the detection linear range of Roche urinary magnesium kit in Hitachi 7180 biochemical analyzer. Methods According to the EP6-A2 file issued by CLSI, 6 different concentration samples with equal intervals were prepared using the high value sample(H) and low value sample(L). Each sample was tested twice by Hitachi 7180 automatic analyzer and the results were analyzed by the SPSS19.0 for polynomial regression analysis. Results The coefficient of variation ratio(CVr)of repeated measurements was 1.48%, which was less than intra-assay imprecision requirements 3.00% stated in the kit instructions. Compared to nonlinear coefficient of cubic regression polynomial b3(t=-2.448, P=0.134), the differences between nonlinear coefficient of quadratic regression polynomial b2(t =-3.958, P =0.029) and 0 was statistically significant, so quadratic regression polynomial was the most suitable polynomial. The linear bias of the first concentration point was(DLi)-(498.00%) which was greater than that of standard(5.00%). Without the first concentration point, the remaining data indicated the differences among nonlinear regression coefficients of quadratic polynomial b2(t =-3.113, P =0.090), the nonlinear coefficient of cubic regression polynomial b2(t=2.708, P=0.225), b3(t=-3.656, P=0.170) and 0 were not significant. The DLi of revised polynomial regression was less than 5.00%. Conclusion Consistent with the linear range stated in the kit instructions, the linearity range of Roche urinary magnesium kit detected by Hitachi 7180 biochemical analyzer was 3.4750~16.8850mmol/L which could meet the needs of clinical routine detection.更多还原