血清肌酐苦味酸法自主研发生化诊断试剂的临床研究

Clinical research on independently researched and developed serum creatinine biochemical diagnostic reagent by Jaffe′s assay

目的评价自主研发的血清肌酐(Cr)生化诊断试剂苦味酸法自身的性能评价及研发试剂与进口优质Cr生化诊断试剂对血清Cr实验检测的可比性及偏倚评估,确认研发试剂是否符合临床要求,能否应用于临床。方法依据美国临床实验室标准化协会EP9-A文件标准,科学设计试验方案。在设置好各种参数的前提下,首先作自主研发血清Cr生化诊断试剂苦味酸法做自身的性能评价:空白吸光度、重复性和线性检测;然后取样本,在奥林巴斯5421型全自动生化仪上进行两种试剂的比对和偏倚评估。结果自主研发血清Cr生化诊断试剂空白吸光度、重复性和线性检测符合要求,X组试剂和Y组试剂对临床标本Cr的检测结果经统计学处理显示:方法内重复性检查DXi′≤4DXi′、DYi′≤4DY′i,离群点检查Eij≤4E,Eij′≤4E′,线性回归r=0.999 8、系统误差的估计值及其置信区间|BClow,BChigh|<允许误差,系统误差符合国际标准要求。结论自主研发的Cr生化诊断试剂与公认的优质进口ROCHE生化诊断试剂间具有良好的相关性,自主研发Cr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 independently researched and developed serum creatinine（Cr） biochemical diagnostic reagent by Jaffe′s assay and to evaluate its comparability and bias with the imported high quality Cr diagnostic reagent to the Cr experimental detection and whether it meets the clinical requirement and can be applied in clinic.Methods According to the EP9-A criterion of USA CLST,the experimental protocol was scientifically designed.On the condition of setting various parameters rationally,the performances of biochemical diagnosis reagent for detecting plasma Cr by Jaffe′s assay was evaluated,which including the detection of blank absorbency,repeatability and linearity.Then,the assessment of comparison and bias results was performed by the Olympus AU5421 automatic biochemical analyzer.Results The detection of the blank absorbance,repeatability and linearity of independently researched and developed serum Cr biochemical diagnostic reagent was up to the mustard.The statistical processing for the serum Cr detection results of clinical specimen by the reagents of X and Y groups showed the intra-method repeatable inspection DX′i≤4DX′i^-,DY′i≤4DY′i^-,the outlier checks：Eij≤4E^-,Eij′≤4E′^-,the linear regression：r=0.999 8,the systematic errors estimates and the confidence interval ｜BClow,BChigh｜〈permissible error and the systematic errors in line with the international standard requirements.Conclusion The independently researched and developed Cr biochemical diagnostic reagent has better relativity with the recognized high quality imported diagnostic reagent.Its security and effectiveness with high quality performance meet the clinical practice requirement.