血清三酰甘油自主研发生化诊断试剂的临床研究

Clinical research of serum triglyceride biochemistry diagnosis reagent of independent research and development

目的进行自主研发的血清三酰甘油(TG)生化诊断试剂的临床研究。方法自主研发血清TG生化诊断试剂自身的性能评价试验包括空白吸光度、重复性和线性检测。与进口优质TG生化诊断试剂进行对比和偏倚评估。结果自主研发血清TG生化诊断试剂空白吸光度、重复性和线性检测符合要求;与进口生化诊断试剂具有良好的相关性。结论自主研发的TG生化诊断试剂自身性能良好,安全性和有效性符合临床应用要求。

Objective To evaluate the performance of independent research and development serum triglyceride（TG） biochemistry diagnosis reagent.Methods Evaluate the performance of independent research and development serum triglyceride biochemistry diagnosis reagent：measures blank absorbance,repeatability and linearity.To evaluate contrast and bias of two reagents in accordance with EP9-A2.Results Blank absorbance,repeatability and linearity of independent research and development serum TG the biochemistry diagnosis regent are up to the mustard.Conclusion The independent research and development TG biochemistry diagnosis reagent is security,effective and meets the clinical practice requirement.