尿微量白蛋白检测试剂盒性能评价

An Evaluation of Urine Microalbuminuria Assay Kit

目的评价北京九强生物免疫比浊法尿微量白蛋白检测试剂盒的性能。方法评价九强生物免疫比浊法检测尿微量白蛋白的精密度、准确度、线性范围、最大稀释倍数、前带性能以及特异性。结果精密度实验显示,日内不精密度高低浓度质控的变异系数(CV)分别为0.61%和0.70%,日间精密度高低浓度质控的CV分别为1.95%和2.83%;准确度实验结果显示,九强生物与罗氏尿微量白蛋白检测试剂盒的检测结果回归方程为Y=1.0169X+5.7251,相关系数(r)为0.9987;测量线性范围与厂家提供的范围一致;最大稀释倍数最大可达40倍;检测样本浓度43000mg/L时前带样本仍在可控范围;在厂家说明书标示的干扰物浓度范围内,对检测结果没有明显影响。结论九强生物的mALB检测试剂盒精密度好、准确度高、线性范围宽、前带性能好,性能完全能满足临床的使用要求。

Objective To evaluate the performance of Beijing Strong Biotechnologies,Inc(BSBE)immune turbidimetry for microalbuminuria measurement.Methods The precision,accuracy,linearity,maximum valid dilute(MVD),hook effect and interference of the BSBE microalbuminuria assay kit(immuneturbidimery method)were all evaluated.Results The high and low values of within-day precision were 0.61% and 0.70% respectively,and between-day CV were 1.95% and 2.83%,respectively.The regression equation and correlation coefficient( r )between BSBE reagent and Roche reagent were Y =1.0169 X +5.7251 and 0.9987,respectively.At the range of 0-400mg/L,there was a good linear relationship between measured values and expected values and the MVD was up to 40 times.The sample concentration of 43000mg/L was still under the controllable range.The common interfering substances listed in the specification had no obvious interference for the test.Conclusion BSBE microalbuminuria assay kit has the good precision,accuracy,linear range,and hook effect for microalbuminuria measurement,and is suitable for the clinical practice.