DOI: 10.57760/sciencedb.j00217.01203
title: Methodological correlation and efficacy analysis of the detection of hepatitis B virus surface antigen
title: 临床实验室检测乙型肝炎病毒表面抗原的方法学关联及效能分析

description: Objective To explore the evaluation and relationship of hepatitis B virus surface antigen in different detection systems.Method 100425 samples were Collected, which were screened, suspected, and confirmed HBV infection patients submitted by clinical departments from June 2021 to July 2022, and used various laboratory methodologies for testing. The linear relationship between two sets of Roche HBsAg detection systems was analyzed using correlation analysis method. HBsAg efficacy analysis was used Cut/Off value setting and detection limit validation.Result There was a good correlation in the low and medium concentrations of HBsAg between the electrochemiluminescence semi method and ELISA method. Performance verification shows that the minimum detection limit of HBsAg in our laboratory was 0.1IU/ml, when the Cut/Off value of ROC curve was set to 0.105, the area under the curve was the largest, AUC=0.986. The frequency of individual HBsAg positivity was the highest during the number of cases of false positive HBsAg detected by ELISA in the five common reporting models of hepatitis B, and as the OD gradually increases from 0.01 to 0.1, the number of false negative cases increased accordingly. Roche detection systems of Elecsys HBsAgⅡquantⅡ and Elecsys HBsAgⅡ had simple mathematical models under certain conditions.Conclusion There was a certain relationship between various detection systems of HBsAg at a suitable concentration. The detection of HBsAg by ELISA could meet the needs of clinical detection.
description: Objective To explore the evaluation and relationship of hepatitis B virus surface antigen in different detection systems.Method 100425 samples were Collected, which were screened, suspected, and confirmed HBV infection patients submitted by clinical departments from June 2021 to July 2022, and used various laboratory methodologies for testing. The linear relationship between two sets of Roche HBsAg detection systems was analyzed using correlation analysis method. HBsAg efficacy analysis was used Cut/Off value setting and detection limit validation.Result There was a good correlation in the low and medium concentrations of HBsAg between the electrochemiluminescence semi method and ELISA method. Performance verification shows that the minimum detection limit of HBsAg in our laboratory was 0.1IU/ml, when the Cut/Off value of ROC curve was set to 0.105, the area under the curve was the largest, AUC=0.986. The frequency of individual HBsAg positivity was the highest during the number of cases of false positive HBsAg detected by ELISA in the five common reporting models of hepatitis B, and as the OD gradually increases from 0.01 to 0.1, the number of false negative cases increased accordingly. Roche detection systems of Elecsys HBsAgⅡquantⅡ and Elecsys HBsAgⅡ had simple mathematical models under certain conditions.Conclusion There was a certain relationship between various detection systems of HBsAg at a suitable concentration. The detection of HBsAg by ELISA could meet the needs of clinical detection.