两种不同品牌谷胱甘肽还原酶检测试剂盒的性能评价

Performance Evaluation of Two Different Brands of Glutathione Reductase Assay Kits

目的评价Beckman Coulter AU5800全自动生化分析仪检测两种不同品牌血清谷胱甘肽还原酶检测试剂盒的分析性能。方法利用CNAS GL-037《临床化学定量检验程序性能验证指南》评估血清谷胱甘肽还原酶检测试剂盒的正确度、精密度、线性范围和参考区间。评价安徽大千生物工程有限公司和山东中拓生物医学工程科技有限公司两种检测试剂盒的分析性能。结果精密度:安徽大千的总精密度为3.31%和1.33%,山东中拓的总精密度为1.74%和2.15%。正确度:安徽大千的偏倚为6.36%,山东中拓的偏倚为8.0%。线性范围:安徽大千的线性范围为10~200U/L,山东中拓的线性范围为4~300U/L。参考范围:安徽大千和山东中拓均为33~73U/L。结论安徽大千和山东中拓的检测性能指标均符合相关要求。利用CNAS GL-037文件同时可进行同一项目不同试剂品牌的性能比较。

Objective This study evaluates the analytical performance of two different brands of serum glutathione reductase test kits using the Beckman Coulter AU5800 fully automated biochemistry analyzer.Methods The ac⁃curacy,precision,linearity,and reference intervals of the serum glutathione reductase test kits were evaluated ac⁃cording to CNAS GL-037"Guidelines for Performance Verification of Clinical Chemistry Quantitative Test Procedures."The analytical performance of the test kits from Anhui Daqian Bioengineering Co.,Ltd.(referred to as Anhui Daqian)and Shandong Zhongtuo Biomedical Engineering Technology Co.,Ltd.(referred to as Shan⁃dong Zhongtuo)was assessed.Results Precision:The total precision of Anhui Daqian was 3.31%and 1.33%,while that of Shandong Zhongtuo was 1.74%and 2.15%.Accuracy:The bias of Anhui Daqian was 6.36%,while that of Shandong Zhongtuo was 8.0%.Linearity:The linear range of Anhui Daqian was 10-200 U/L,and that of Shandong Zhongtuo was 4-300 U/L.Reference interval:Both Anhui Daqian and Shandong Zhongtuo had a reference interval of 33-73 U/L.Conclusion The analytical performance indicators of both Anhui Daqian and Shandong Zhongtuo comply with the relevant requirements.Using the CNAS GL-037 document enables per⁃formance comparison of different reagent brands for the same test.