同型半胱氨酸检测试剂盒性能评价  

Evaluation of performance of homocysteine test kit

作　　者：张立敏[1] 胡金川[1] 魏金凤[1] 李岩[1] 

机构地区：[1]中国人民解放军第281医院检验科,河北秦皇岛066100

出　　处：《国际检验医学杂志》2014年第23期3249-3250,共2页International Journal of Laboratory Medicine

摘　　要：目的：评价国内某公司同型半胱氨酸（Hcy）试剂性能指标，探讨其临床应用价值。方法利用奥林巴斯 Au640生化仪对 Hcy 试剂盒进行准确度、重复性、稳定性、线性范围等方法学评价。结果正常值质控和病理值质控测定相对偏倚分别为0.2％和4.9％，远小于试剂说明书要求的小于15％；批内变异百分率分别为2.6％和2.3％，小于试剂说明书要求的小于5％；天间变异百分率分别为4.4％和4.1％，小于试剂说明书要求的小于10％。在0～66μmol／L 浓度范围内，复相关系数 r2为0.997，说明预期值与测量值之间相关性极好；斜率 b1＝0.9799，在0.97～1.03范围内，从经验上判断，斜率与1之间无差异，截距 b0＝0.1518，与0之间无差异，表明该试剂在实验所涉及的浓度范围内（0～66μmol／L）检测结果呈线性。结论国内某公司 Hcy 试剂各方面性能指标优异，适于临床应用。Objective To evaluate the performance of homocysteine（Hcy）test kit produced by a domestic company and to inves-tigate its feasibility in clinical application.Methods A series of methodological evaluation experiments including the accuracy,re-peatability,stability and linear range of the Hcy reagent kit were carried out on the Olympus Au640 biochemistry analyzer.Results The experiments showed that the relative biases of detection results of normal value quality control serum and pathological value quality control serum were 0.2% and 4.9%,respectively,which were far less than 15% of the reagent instruction.The intra-assay coefficients of variation（CV）of normal and pathological quality control serum were 2.6% and 2.3% respectively,which were less than 5% of the reagent instruction.While the inter-assay CV of normal and pathological quality control serum were 4.4% and 4.1% respectively,which were less than 10% of the reagent instruction.The experiments for the linear range evaluation showed that R 2 was 0.997 in the concentration range of 0 -66 μmol/L,which suggested that the correlation between expected value and measured value was very well.Otherwise,the slope rate b1 of 0.979 9 and the intercept b0 of 0.151 8 were both showed that the de-tection results of Hcy reagent were linear in the concentration of 0-66 μmol/L.Conclusion The performance of Hcy kit produced by a domestic company is very good in the performance indexes of accuracy,repeatability,stability,and linear range and suitable for the clinical application.

关 键 词：同型半胱氨酸 性能评价 试剂盒 

分 类 号：R446.1[医药卫生—诊断学]