直接法测定低密度脂蛋白胆固醇(LDL-C)试剂性能评价

Determination of Low Density Lipoprotein Cholesterol(LDL-C) in Serum or Plasma by Direct Method Test

目的:评价国产低密度脂蛋白胆固醇(LDL-C)直接法检测试剂盒性能。方法:利用日立7180全自动生化分析仪对国产LDL-C试剂进行一系列方法学评价比较试验。结果:批内CV<3.0%,批间CV<4.0%;线性范围可达0.02～12.00mmol/L;抗干扰能力:当样品中血红蛋白达5000mg/L,胆红素达1000umol/L,甘油三酯达5mmol/L,以及常用的正常用量的抗凝剂,均不干扰测定结果;与某进口试剂比较,回归方程为:y=1.0619x-0.0766,r=0.9967。结论:该试剂使用方便、快速、准确,适用于自动化分析。

Objective：To appraise low density lipoprotein cholesterol （LDL-C） direct test kit produced by Sichuan Maker Science and Technology CO.,LTD.Methods：LDL-C was detected with a series of tests on HITACHI 7180 Automatic Analyzer.Results：Within-day CV was less than 3.0%;between-day CV was less than 4.0%;linearity was up to 12.00mmol/L.Method Comparison：A comparison between Point LDL-C （y） and Maker LDL-C （x） gave following Results：y=1.0619x-0.0766;r=0.9967.Conclusion：Maker reagent is easy to use,fast and accurate and suitable for automation analysis.