酶联免疫分析检测乙型肝炎e抗原的空白限、检出限及定量限的建立与评价

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0．131 PEI U ／mL ，LoD 为0．350 PEI U ／mL ，LoQ 为0．450 PEI 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 enzyme‐linked 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 concen‐tration 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 manufac‐turer 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 .