全自动酶联免疫吸附法检测血清乙型肝炎表面抗原检测限的建立与评价

The establishment and evaluation of limit of detection for detection of serum hepatitis B surface antigens by Automatic enzyme-linked immunosorbent assay

目的建立全自动酶联免疫吸附法(ELISA)检测血清乙型肝炎表面抗原(HBsAg)的检测限并进行评价.方法参考美国临床实验室标准委员会(CLSI)EP17-A文件,对全自动酶联免疫酶联免疫吸附法检测血清乙型肝炎表面抗原(HBsAg)结果的分布进行统计描述,建立全自动酶联免疫吸附法检测血清乙肝表面抗原的检测限.结果空白限(LOB)为0.027μg/L,检出限(LOD)为0.083μg/L,定量限(LOQ)为0.125μg/L.结论参考CLSI EP17-A文件建立的全自动ELISA法检测限更能满足临床实验室的要求,为临床提供可靠的检验结果.

Objective The establishment and evaluation of limit of detection to detect serum hepatitis B surface antigens by Automatic enzyme-linked immunosorbent assay.Methods Referring to the Clinical and Laboratory Standards Institute(CLSI)EP17-A file,using the statistical methods to describe the results of Automatic enzyme-linked immunity assay,establishing automated ELISA’s limit of detection to detect serum hepatitis B surface antigen(HBsAg).Results The results were that LOB=0.027μg/L,LOD=0.083μg/L,LOQ=0.125μg/L.Conclusion The Automatic ELISA limit of detection established byreferring to the file of CLSI EP17-A was better meet the requirements of clinical laboratories,provide reliable results for clinical laboratories.