摘要
目的建立并评价酶联免疫分析手工操作检测HBeAg的空白限(LoB)、检出限(LoD)及定量限(LoQ)。方法参照美国临床实验室标准化协会EP-17A文件和有关文献,结合工作实际,将HBeAg的空白样品及系列低浓度样品进行酶联免疫分析手工操作的检测,根据数据的分布规律,采用相应的统计学方法,建立酶联免疫分析手工操作检测HBeAg的LoB、LoD及LoQ并进行评价。结果 HBeAg的LoB为0.131PEI U/mL,LoD为0.350PEI U/mL,LoQ为0.450PEI U/mL。结论厂商声明的LoB得到验证,同时建立了实验室检测HBeAg的LoB、LoD和LoQ,为临床诊断和治疗提供更有价值的信息。
Objective To establish the limit of blank（LoB） ,limit of detection（LoD） and limit of quantitation （LoQ） for the detection of HBeAg by the enzymelinked immunosorbent assay .Methods Referring to CLSI EP‐17A protocol and related literature ,and by combining with our actual works ,the blank sample and a series of low concenration samples were performed the ELISA detection by the manual operation .According to the distribution law of the data ,the corresponding statistical method was adopted to establish the ELISA detection of LoB ,LoD and LoQ of HBeAg by the manual operation .Results LoB of HBeAg measured by the manual operation was 0 .131 PEI U /mL , LoD was 0 .350 PEI U /mL and LoQ was 0 .450 PEI U /mL .Conclusion The LoB of HBeAg stated by the manufacturer is verified .At the same time ,LoB ,LoD and LoQ of HBeAg detected by our laboratory are established ,which provide more valuable information for the clinical diagnosis and therapy .
出处
《检验医学与临床》
CAS
2015年第18期2656-2658,共3页
Laboratory Medicine and Clinic
基金
卫生部医药卫生科技发展研究中心资助项目(28-1-45)
关键词
乙型肝炎E抗原
酶联免疫吸附试验
空白限
检出限
定量限
HBeAg
enzyme-linked immunosorbent assay
limit of blank
limit of detection
limit of quantitation
