用EP6-A2方法验证比色法检测血清超氧化物歧化酶

Demonstration of linear range of Superoxide Dismutase activity colorimetric kit by EP6-A2 method

目的用EP6-A2方法验证比色法测定超氧化物歧化酶（SOD）试剂线性范围，对该试剂盒的性能进行初步评价，为临床提供一种线性范围较宽、准确性好、使用方便、适合临床需求的良好检测试剂。方法根据临床和实验室标准化协会fCLSI）颁发的EP6-A2文件，配制6个试验样本，按随机顺序对它们进行测定，每个样本重复测定2次。经离群点检查后计算不精密度（SDJ、多项式回归系数（bi）标准误（Syx）、线性偏离（DLi）。结果所有测试结果未发现离群点。二次回归多项式非线性系数b2、三次回归多项式非线性系数b2、b3与“0”均无显著性差异（P〉0．05），一次回归多项式为最适多项式。结论比色法测定SOD试剂盒在0．250U／ml范围内呈线性．与试剂盒说明的线性范围相一致，完全能满足实验室及临床需求。

Objective To demonstrate the linear range of Superoxide Dismutase （SOD） activity colorimetric kit by the EP6-A2 method, and evaluate the performance of this kit. Methods According to the EP6-A2 document that issued by Clinical and I.abo- ratory Standards Institute（CLSI）, 6 samples were prepared and detected in duplicate in random order. After outlier test, the propor- tional error（SDr）, polynomial regression coefficients （hi）, standard error （Syx） and deviation from linearity （DLi） were calculated. Results No outlier was found in all test results. There was no statistically significant difference between zero and nonlinear coeffi- cient b2 in quadratic regression polynomial, so were b2 and b3 in cubic regression polynomial（P〉0.05）. The linear was the best re- gression polynomial. Conclusion The detecting linear range of SOD assay kit used in our laboratory is 0-250U/ml, in accordance with statement of kit instructions.