血清镁自主研发生化诊断试剂的临床研究

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

目的进行国内自主研发的中生北控生物科技公司(中生)血清镁(Mg)诊断试剂的临床研究。方法中生血清Mg生化诊断试剂的自身性能评价包括空白吸光度、重复性和线性检测。以日本进口Olympus诊断试剂为对照,与对照试剂进行临床比对和偏倚评估。结果中生血清Mg生化诊断试剂空白吸光度、重复性和线性检测符合要求;2种试剂重复性良好,无离群点,线性回归r=0.995 8,系统误差的估计值及其置信区间符合国际标准要求。结论自主研发的Mg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 magnesium（Mg） biochemistry diagnosis reagent. Methods Evaluate the performance of independent research and development serum Mg biochemistry diagnosis reagent：measure blank ahsorbance, repeat ability and linearity. To evaluate contrast and bias of two reagents in accordance, take imports the biochemistry diagnosis reagent of Japanese Olympus as the control group. Results Blank absorbance, repeatability and linearity of Mg are up to the mustard, r： 0. 995 8, systematic errors in line with international standard requirements. Conclusion The independent research and development Mg biochemistry diagnosis reagent is security, effective and meets the clinical practice requirement.