血清肌酸激酶自主研发生化诊断试剂的临床研究

Clinical research on independently researched and developed serum creatine kinase biochemical diagnostic reagent

目的进行自主研发的血清肌酸激酶(CK)生化诊断试剂自身的性能评价及研发试剂与进口优质CK生化诊断试剂对CK实验诊断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。方法自主研发血清CK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EP9-A文件标准,科学设计试验方案,以进口德国Olympus(Olympus)的诊断试剂为对照组(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Olympus AU5421自动生化分析仪上测定血清CK含量。标本选择高、中、低值CK含量的临床患者血清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,作统计学分析。结果自主研发血清CK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CK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 3、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CK生化诊断试剂与公认的优质进口Olympus生化诊断试剂两者间具有良好的相关性;自主研发的CK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 creatine kinase（CK） biochemical diagnostic reagent and to evaluate its comparability and bias with the imported high quality CK diagnostic reagent to the CK experimental detection and whether it meets the clinical requirement and can be applied in clinic.Methods The performance of independently researched and developed serum CK biochemical diagnostic reagent was evaluated,which including the blank absorbance,repeatability and linearity.The comparison and bias of two kinds of reagents were performed in accordance with EP9-A criterion of USA CLSI.The experimental protocol was scientifically designed with the imported biochemical diagnostic reagent of German（Olympus） as the control group（X） and the biochemical diagnostic reagent of domestic Zhongsheng as the experimental group（Y）.The serum CK content was detected by Japanese Olympus AU5421 automatic biochemistry analyzer.100 specimens containing high,middle and low contents of serum CK 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 CK biochemical diagnostic reagent conformed to the requirements.The statistical processing for the serum CK detection results of clinical specimen by the reagents of X and Y groups showed the intra-method repeatable inspection：DX′i≤4DX′^-,DY′i≤4DY′^-,the outlier checks Eij≤4E^-,Eij′≤4E′^-,the linear regression r=0.999 3,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 CK 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.