国产与进口试剂检测人血清中乙型肝炎表面抗体结果差异分析  

Analysis on The Difference of Domestic and Import Kits for Determination of Anti-HBs in Human Serum

作　　者：孙文萱[1] 李冰[1] 马茹[1] 余峰 马莉 

机构地区：[1]河南省新乡市中心医院,453000 [2]郑州安图绿科生物工程有限公司

出　　处：《职业与健康》2010年第10期1116-1117,共2页Occupation and Health

摘　　要：目的分析国产试剂与进口试剂检测乙型肝炎病毒表面抗体(抗-HBs)结果差异。方法选取新乡市中心医院住院和门诊病人血清标本44份,分别用罗氏全自动化学发光试剂和郑州安图生物化学发光试剂测定抗-HBs浓度,挑选阴阳性结果有差异的样本,再用国内主流试剂进行复测。结果郑州安图生物和罗氏试剂检测结果一致的百分比为95.5%,其中2份样本罗氏阴阳性结果与国内试剂存在反差。结论国产试剂与进口试剂检测抗-HBs结果存在一定的偏差,在一定程度上与包被和标记用HBsAg有关。[Objective]To analyze the difference between domestic and import kits for the determination of anti-HBs in human serum.[Methods]Totally 44 serum samples of inpatient and outpatient in Xinxiang Central Hospital were collected for determination of the concentration of anti-HBs by Roche ECLIA and Autobio CLIA Test Kits.The samples,which had different results by the above methods,were selected for retesting by the domestic main kits.[Results]The coincidence rate for anti-HBs between results of kits from Autobio and Roche ECLIA was 95.5%.Two samples had different results.[Conclusion]There is a certain difference exists in detecting anti-HBs between domestic and import Kits,which may relates with coating and labeling to a certain extent.

关 键 词：国产试剂 进口试剂 表面抗体 化学发光法 包被 标记 表面抗原 

分 类 号：R446.6[医药卫生—诊断学]