自主研发血清淀粉酶生化诊断试剂的临床研究

About the Clinical Research of Serum Amylase Biochemistry Diagnosis Reagent of Independent Research and Development

目的进行自主研发的血清淀粉酶（AMY）生化诊断试剂自身的性能评价及研发试荆与进口优质AMY生化诊断试剂对血清AMY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AMYEPS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侍评估依据美国（CLSI）EP9～A文件标准，科学设计试验方案，以进口德国ROCHE（ROCHE）的诊断试荆为对照组（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AMY单位含量。标本选择高、中、低值血清AMY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AMY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AMY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’。≤4DY’、离群点检查Eij≤4E，Eij’≤4-E’、线性回归R=0．9995，系统误差的估计值及其置信区间〈允许误差，系统误差符合国际标准要求。结论自主研发的AMY生化诊断试剂与公认的优质进口ROCHE生化诊断试剂两者间具有良好的相关性；自主研发AMY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 AMY（serum amylase） the biochemistry diagnosis reagent and to evaluate it and the import high quality AMY diagnosis reagent to the AMY experiment diagnostic of comparability and bias. Whether the confirmation research and development reagent does meet the clini- cal requirement. Methods Evaluate the performanceof independent research and development serum AMY the biochemistry diagnosis reagent by EPS method .-Measurese blank absorbance,repeatability and linearity. To evaluate Contrast and bias of two reagents in accordance with EPg-AE13,Science designs to experiment a project,take imports the biochemistry di- agnosis reagent of German ROCHE as the control group （X）,the biochemistry diagnosis reagent of domestic Zhongsheng as the experimental group （Y）. Measurese the serum AMY content in Japanese OLYMPUS AU5421 automatic biochemistry analyzer. Chooses AMY of high,middle,low content clinical blood serum specimen 100,ten everydays. The results were recorded and statistical analysis was performed. Results Blank absorbance,repeatability and linearity of independent research and development serum AMY the biochemistry diagnosis reagent is up to the mustard. Through an examination for the clinical specimen with the X set reagent and the Y set reagent AMY get result,use of statistic software show that： Methods with in the repetitive inspectionDX＇i4 DX＇ ,DY＇~4 DY＇ ,Outlier checks ,Linear regression R=0. 999 5,Systematic errors estimates and confidence interval Permissible error,systematic errors in line with International standard requirements. Conclusion The independent research and development＇s AMY biochemistry diagnosis reagent and the recognition high quality import to diagnose reagent both to have the good the relevance. High quality performance of The independent research and development＇s AMY biochemistry diagnosis reagent are security,effective and meet the clinical practice requirement.