一种过氧化物酶法sdLDL-C测定试剂的性能评价

The Evaluation of a Peroxidase sdLDL-C Reagent

目的评价一种过氧化物酶法sdLDL-C测定试剂的分析性能。方法参考CLSI EP文件要求对此过氧化物酶法sdLDL-C测定试剂的正确度、精密度、线性、回收实验以及参考区间进行评价,并与DENKA SEIKEN sdLDL-C测定试剂进行方法学比对。结果sdLDL-C测定试剂的正确度、精密度、线性和回收率均达到性能评价标准,其中批内精密度为低浓度3.80%、高浓度2.25%;批间精密度为低浓度3.01%、高浓度2.89%。实测线性范围为0.071~2.533 mmol/L。平均回收率为93.51%。150例表观健康受试者的参考范围为0.14~0.58 mmol/L。与DENKA SEIKEN sdLDL-C测定试剂的检测值拟合方程为Y=0.9666X-0.0031,决定系数R2=0.9991。结论sdLDL-C测定试剂的正确度、精密度、线性、回收率均达到性能评价标准,在临床应用中与DENKA SEIKEN试剂相关性良好,具有临床适用性。

Objective To evaluate the analytical properties of sdLDL-C reagent by peroxidase method.Methods The accuracy,precision,linearity,recovery experiment and reference interval of sdLDL-C were evaluated according to the document of CLSI EP.The results were compared with results of DENKA SEIKEN reagent.Results The accuracy,precision,linearity and recovery of Mindray sdLDL-C reagent all met the performance evaluation standard.The repeatability were 3.80%and 2.25%,respectively,and the total CVs were 3.01%and 2.89%,respectively.The measured linear range was 0.071~2.533 mmol/L,while the average recovery rate was 93.51%,and the reference range of 150 apparent health subjects was 0.14~0.58 mmol/L.The fitting equation of the detection value with DENKA SEIKEN sdLDL-C reagent was Y=0.9666X-0.0031,and the correlation coefficient R2 was 0.9991.Conclusion The accuracy,precision,linearity and recovery of sdLDL-C reagent all meet the performance evaluation standards.It has a good correlation with DENKA SEIKEN reagent in clinical applications and has a clinical applicability.