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 r2=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.