血清胆固醇自主研发生化诊断试剂的临床研究

目的进行自主研发的血清胆固醇(CHO)生化诊断试剂自身的性能评价及与进口优质CHO生化诊断试剂对血清CHO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。方法自主研发的血清CHO COD-PAP法生化诊断试剂自身的性能评价做空白吸光度、重复性和线性功能评价。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,以进口日本Olympus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),在奥林巴斯(Olympus)AU5421自动生化分析仪上测定血清CHO含量。标本选择高、中、低值血清CHO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CHO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CHO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r2=0.995、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CHO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CHO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。

Clinical research of serum cholesterin biochemistry diagnostic reagent by independent research and development

Objective To evaluate the performance of independently developed serum cholesterin（CHO） biochemistry diagnostic reagent and to evaluate the comparability and bias of the results between the independently developed reagent and the imported high quality CHO diagnostic reagent.Then figure out if the reagent meets the clinical application requirements.Methods The performance evaluation of the independently developed of biochemistry diagnostic reagent of CHO was tested by COD-PAP method：measuring blank absorbance,repeatability and linearity.To evaluate the contrast and bias of two reagents in accordance with EP9-A [1],the experiment was designed properly.Take imports the biochemistry diagnosis reagent of Japanese Olympus as the control group（X）,the biochemistry diagnosis reagent of domestic Zhongsheng as the experimental group（Y）.To measure the serum CHO content on Olympus AU5421 automatic biochemistry analyzer.100 specimens containing high,middle and low contents of serum CHO from clinical patients were selected and 10 specimens were taken per day,each specimen was delected by positive sequence and reverse sequence.The results were recorded and statistical analysis was performe.Results Blank absorbance,repeatability and linearity of independently researched and developed serum CHO biochemistry diagnosis reagent was in line with the standards.Through an examination for the clinical specimen with the X set reagent and the Y set reagent CHO,getting results,by using statistic software showed that：methods with in the repetitive inspection DX′i≤4DX′^-,DY′i≤4DY′^-,outlier checks Eij≤4E^-,Eij′≤4E′^-,linear regression r^2=0.995,systematic errors estimates and confidence interval ｜BClow,BChigh｜〈permissible error,systematic errors in line with International standard requirements.Conclusion The independently developed CHO biochemistry diagnosis reagent and the recognited high quality imported diagnostic reagent both have the good the relevance.High quality performance of independently researched and developed CHO biochemistry diagnostic reagent is safe,effective and meets the clinical practice requirement.