血清肌酐酶法自主研发生化诊断试剂的临床研究

Clinical study on independently researching and developing serum creatinine biochemical diagnostic reagent by enzymatic assay

目的自主研发的血清肌酐(Cr)酶法生化诊断试剂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。方法进行自主研发血清Cr生化诊断试剂自身的性能评价:做空白吸光度、重复性和线性检测。两种试剂的比对和偏倚评估依据美国临床实验室标准化协会(CLSI)EP9-A文件标准,科学设计试验方案,以进口德国ROCHE(ROCHE)诊断试剂为对照组(X),国内中生北控生物科技公司(中生)诊断试剂为实验组(Y),在日本奥林巴斯(Olympus)AU5421自动生化分析仪上测定血清Cr含量。标本选择高、中、低值血清Cr含量的临床患者血清共计100份,每天10份,每份标本正序、倒序各测定1次,记录测定结果,做统计学分析。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组试剂对临床标本血清Cr的检测结果经统计学处理显示:方法内重复性检查DXi′≤4DX′、DYi′≤4DY′,离群点检查Eij≤4E,Eij′≤4E′、线性回归r=0.999 9、系统误差的估计值及其置信区间|^BClow,^BChigh|小于允许误差,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生化诊断试剂二者间具有良好的相关性;自主研发的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 enzymatic 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 The performance of independently researched and developed serum Cr biochemical diagnostic reagent was evaluated,which including the blank absorbance,repeatability and linearity.The comparison and bias evaluation on two kinds of reagents was performed in accordance with EP9-A criterion of USA CLSI.To scientifically design the experiment protocol with the imported biochemical diagnostic reagent of German ROCHE as the control group（X） and the biochemical diagnostic reagent of domestic Zhongsheng as the experimental group（Y）.The serum Cr content was detected by the Japanese Olympus AU5421 automatic biochemistry analyzer.100 specimens containing high,middle and low contents of serum Cr from clinical patients were selected and each specimen was detected once by positive sequence and reverse sequence.The results were recorded and statistically analyzed.Results The detections of blank absorbance,repeatability and linearity of independently researched and developed serum Cr biochemical diagnostic reagent conformed to the requirements.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：DXi′≤4DX′,DYi′≤4DY′,the outlier checks：Eij≤4E,Eij′≤4E′,the linear regression：r=0.999 9,the systematic errors estimates and confidence interval ｜Clow,Chigh｜permissible error and the systematic errors in line with 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.