Establishment and evaluation of a confirmation method for hepatitis B surface antigen
10.3969/j.issn.1000-484X.2025.09.032
- VernacularTitle:乙型肝炎表面抗原确认方法的建立及评价
- Author:
Juying WANG
1
;
Tingting JI
1
;
Yaoyao LIU
1
Author Information
1. 宁夏医科大学总医院,银川 750004
- Publication Type:Journal Article
- Keywords:
HBsAg;
False positive;
Neutralizing antibody;
Confirmation method;
Establishment;
Evaluation
- From:
Chinese Journal of Immunology
2025;41(9):2251-2254
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish and evaluate a confirmation method for hepatitis B surface antigen(HBsAg)based on chemiluminescent immunoassay and neutralization test.Methods:①Detection procedure of the confirmation method:Initially,optimal concentration of neutralizing antibody was determined through a preliminary trial.During the confirmation of HBsAg,in the detection cups and control cups already containing test serum,neutralizing antibody and pre-test four items(hepatitis B serological markers,HCV antibody,syphilis spiral body antibody,HIV antibody)negative serum were added in a 1∶1 ratio(100 μl∶100 μl),respectively.After thorough mixing,the mixture was incubated at 37℃for 30 min,and the pre-treated serum was tested using the Siemens Atellica IM HBsAg detection program.②Reliability evaluation of the confirmation method:Coincidence rate of the confirmation method results and the Siemens confirmation reagent test results for 64 serum samples with different concentrations of HBsAg reactivity was compared and analyzed.③Determination of the diagnostic value and positive judgment value of the confirmation method:Taking the Siemens confirmation reagent test results for 64 HBsAg reactive serum samples as"the gold standard",neutralization rate of the confirmation method test results was statistically analyzed using ROC curve.Results:①In the preliminary trial,when the concentration of HBsAb was≥1 285.12 mU/ml,neutralization rate of the test results was>50%,and the neutralization rate was increased with the concentra-tion of HBsAb.After the same concentration of HBsAb neutralized different concentrations of HBsAg,trend of the neutralization rate change was not significant.②Coincidence rate of the two methods was 100.00%.③Area under the curve(AUC)was 0.993 4,the pos-itive judgment value was neutralization rate≥47.93%,with a sensitivity of 98.15%and specificity of 100.00%.Conclusion:This de-tection method is simple,easy-to-use,cost-effective,and has high diagnostic value,suitable for confirming HBsAg at different con-centrations.
