检测乙肝病毒标志物的不同方法的临床免疫室间质量评价

The Clinical Immunological Chamber Quality Evaluation of Detection of Hepatitis B Virus Markers by Different Methods

目的:评价不同乙肝病毒标志物检测方法的临床免疫室间质量。方法:某省临床检验中心2014年、2015年发放的乙肝病毒标志物标本,分别采用ELISA(酶联免疫吸附法)和金标法检测HBsAg、HBsAb、HBeAg、HBeAb、HBcAb,每种检测方法均在两个实验室内开展。结果:金标法、ELISA各自在两个实验室检测五项指标的正确率比较均无明显差异(P>0.05),临床免疫室间质量比较无明显差异(P>0.05),但两种检测方法两个实验室检测乙肝病毒标志物HBsAb、HBeAg的正确率比较存在的差异均具有统计学意义(P<0.05)。结论:与ELISA比较,金标法用于检测乙肝病毒标志物的准确率和临床免疫室间质量更高,所具有的临床推广应用优势更明显。

Objective： To evaluate the quality of Clinical immunization of different hepatitis B virus markers. Methods： The hepatitis B virus markers specimens in Provincial Clinical Laboratory Center in 2014, 2015 were analyzed by ELISA （enzyme-linked immunosorbent assay） and gold standard method to detect the HBsAg,HBsAb,HBeAg,HBeAb, HBcAb. Each test method was carried out in different laboratories. Results： The correct rate of two methods of five indicators had no significant differences （P〉0.05）. There was no significant difference in the quality of clinical immunocytochemistry （P〉0.05）, but the correct rate of two tests methods for the detection of HBsAb and HBeAg in hepatitis B virus markers was statistically significant （P 〈0.05）. Conclusion： Compared with ELISA, the gold standard method is used to detect the accuracy of hepatitis B virus markers and the quality of clinical immunization chamber, which has obvious advantages in clinical application.