自主研发血清葡萄糖生化诊断试剂的临床研究

Clinical Research on Serum Glucose of Hexokinase Method Biochemistry Diagnosis Reagent of Independent Research and Development

目的 进行自主研发的血清葡萄糖（Glu）生化诊断试剂自身的性能评价及研发试剂与进口优质Glu生化诊断试剂对血清Glu试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Glu己糖激酶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（CLSI）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）诊断试剂为试验组（Y）,在日本奥林巴斯（OLYMPUS） AU5421自动生化分析仪上测定血清Glu含量.标本选择高、中、低值Glu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Glu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Glu的检测结果经统计学处理显示：方法内重复性检查,DX′i≤4DX′^-,DY′i≤4DY′^-、离群点检查Eij≤4E,Eij′≤4E^-′、线性回归r=0.999 8,系统误差的估计值及其置信区间 ｜（B）clow,（B）chigh｜＜允许误差,系统误差符合国际标准要求.结论 自主研发的Glu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Glu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 independent research and development Glu （serum glucose）the biochemistry diagnosis reagent and to evaluate it and the import high quality Glu diagnosis reagent to the Glu experiment diagnostic of comparability and bias,whether the confirmation research and development reagent does meet the clinical requirement. Methods Evaluated the performance of independent research and development serum Glu the biochemistry di- agnosis reagent by HK method ：measured blank absorbanee repeatability and linearity. To evaluate Contrast and bias of two reagents in accordance with EP9-A,scienee designs to experiment a project, took imports the biochemistry diagnosis reagent of German OLYMPUS as the control group（X） ,the biochemistry diagnosis reagent of domestic Zhongsheng as the experimental group（Y）. Measured the serum Glu content in Japanese OLYMPUS AU5421 automatic biochemistry analyzer. Chose Glu of high ,middle and low content clinical blood serum specimen 100, ten everydays. The results were recorded and statistical analysis was performed. Results Blank absorbanee,repeatability and linearity of independent research and development serum Glu the biochemistry diagnosis reagent was up to the mustard. Through an examination for the clinical specimen with the X set reagent and the Y set reagent Glu got results,use of 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=0. 999 5, systematic errors estimates and confidence interval ｜（B）clow,（B）chigh｜〈permissible error,systematic errors in line with interna- tional standard requirements. Conclusion The independent research and development＇s Glu biochemistry diagnosis reagent and the recognition high quality import to diagnose reagent both to have a good relevance. High quality performance of the independent research and development＇s Glu biochemistry diagnosis reagent are security effective and meet the clinical practice requirement.