血清磷自主研发生化诊断试剂的临床研究  

Clinical research on independently developed biochemistry diagnostic reagent of serum phosphorus

作　　者：佘文婕[1] 王惠萱[1] 贾雄飞[1] 滕毅[1] 王珂[1] 陈忠明[1] 毕再华[1] 

机构地区：[1]解放军昆明总医院检验科,昆明650032

出　　处：《检验医学与临床》2011年第6期641-643,共3页Laboratory Medicine and Clinic

基　　金：国家高技术研究发展计划"863计划"重点课题(2006AA020901)

摘　　要：目的进行自主研发的血清磷(P)生化诊断试剂自身的性能评价及研发试剂与进口优质P生化诊断试剂对血清P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。方法自主研发血清P磷钼酸紫外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)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P含量。标本选择高、中、低值P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,作统计学分析。结果自主研发血清P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P的检测结果经统计学处理显示:方法内重复性检查DXi′≤4DX′、DY′i≤4DY′,离群点检查Eij≤4E,Eij′≤4E′、线性回归r=0.997 3、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P生化诊断试剂与公认的优质进口O-lympus生化诊断试剂两者间具有良好的相关性;自主研发P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 developed biochemistry diagnosis reagent of serum phosphorus（P）and to assess the comparability and bias of the results from the independently developed reagent and the imported high quality P diagnostic reagent.Then figure out if the reagent meets the clinical application requirements.Methods The performance evaluation of the independently developed biochemistry diagnostic reagent of P was tested by phosphorus reagent kit,including blank absorbance,repeatability and linearity tests.The comparison and bias evaluation of the two reagents was in accordance with EP9-A,and the experiment was designed properly.We took imported biochemistry diagnostic reagent of German Olympus as the control group（X）,and the biochemistry diagnosis reagent from domestic Zhongsheng as the experimental one（Y）.We tested the serum P content by Japanese Olympus AU5421 automatic biochemistry analyzer.100 specimens containing high,middle and low P contents 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 performed.Results Blank absorbance,repeatability and linearity of the independently developed biochemistry diagnostic reagent of serum P was in line with the standards.According to the statistic software,the test results of P using X set reagent and Y set reagent respectively showed that：repetitive inspection within methods showed DX′i≤4DX′^-、DY′i≤4DY′^-.Outlier test result was Eij≤4E^-,Eij′≤4E′^-.Linear regression r=0.997 3.Systematic errors estimate value and confidence interval ｜BClow,BChigh｜〈permissible error,as a result systematic errors was in line with international standard requirements.Conclusion The results of the independently developed biochemistry diagnostic reagent of P and the imported high quality P diagnostic reagent have high degree of correlation.The independently developed biochemistr

关 键 词：血清磷 诊断试剂 临床研究 

分 类 号：R446[医药卫生—诊断学]