血清AST自主研发生化诊断试剂的临床研究  

Clinical application of independently researched and developed diagnostic reagent for the detection of serum AST

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

机构地区：[1]中国人民解放军昆明总医院检验科,650032

出　　处：《国际检验医学杂志》2011年第16期1787-1788,1791,共3页International Journal of Laboratory Medicine

基　　金：国家高技术研究发展计划"863计划"(2006AA020901)

摘　　要：目的对自主研发的血清天门冬氨酸氨基转移酶(AST)生化诊断试剂进行自身的性能评价,并与进口血清AST生化诊断试剂对血清AST试验检测的可比性及偏倚进行评估。方法自主研发血清AST生化诊断试剂自身性能评价:做空白吸光度、重复性和线性检测。依据美国临床实验室标准化委员会(CLSI)EP9-A文件标准,科学设计试验方案,与进口德国Olympus生化诊断试剂进行比对和偏倚评估研究。结果自主研发AST生化诊断试剂空白吸光度、重复性和线性检测均符合要求,两组试剂对临床标本AST的检测结果系统误差符合国际标准。结论自主研发AST生化诊断试剂与进口生化诊断试剂两者间具有良好的相关性,并且自身性能良好,安全性和有效性符合临床应用要求。Objective To evaluate the performance of independently researched and developed diagnostic reagent for the detection of serum aspartate aminotransferase（AST） and its comparability and bias with imported diagnostic reagent.Methods The performance of independently researched and developed reagents was evaluated by the testing of blank absorbance,repeatability and linearity .According to the document EP9-A of Clinic and Laboratory Standard Institute （CLSI）,the comparability and bias between independently researched and developed reagent and imported diagnostic reagent of Olympus from German were assessed.Results The blank absorbance,repeatability and linearity of independently researched and developed AST diagnostic reagent were all in line with the requirements. The systematic errors between the two different reagents were also in line with international standards.Conclusion There is fine correlation between independently researched and developed AST diagnostic reagent and the imported reagent,and the performance,safety and validity of the former could meet the requirements of clinical practice.

关 键 词：天冬氨酸氨基转移酶类 诊断 指示剂和试剂 生物医学研究 

分 类 号：R446.1[医药卫生—诊断学]