ISSN: 0973-7510

E-ISSN: 2581-690X

Research Article | Open Access
Mridula Madiyal1 , Shashidhar Vishwanath2 and Shiran Shetty3
1Department of Microbiology, K.S. Hegde Medical Academy (KSHEMA), NITTE (Deemed to be University), Mangalore, Karnataka, India.
2Department of Microbiology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India.
3Department of Gastroenterology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India.
Article Number: 9105 | © The Author(s). 2024
J Pure Appl Microbiol. 2024;18(1):549-554.
Received: 04 November 2023 | Accepted: 19 January 2024 | Published online: 29 February 2024
Issue online: March 2024

Hepatitis B surface antigen (HBsAg) is the important marker in diagnosis and decision making of Hepatitis B infection. Equivocal results are common diagnostic challenges with HBsAg. The study evaluates the role of neutralization assay in equivocal HBsAg results. Serum samples which documented equivocal or low positive COI where subjected to HBsAg neutralization assay. Percentage reduction in false positivity and recommended COI for deciding the assay was calculated. A subset of samples was subjected to molecular confirmation. Analysis of 51 samples showed 87.71% reduction in false positivity by using neutralization assay. 9.17 was the COI which showed highest AUC (0.702). Percentage positivity of molecular analysis of 13 samples was 70% (9/13). The optimum COI for utilizing neutralization assay is high from the study which is probably due to the high mean COI (12.1) of the included samples. Use of follow up HBsAg neutralization assay is recommended in equivocal HbsAg results to confirm the interpretation. However, the cut-off COI for implementation of test may vary for different population and analysers used for testing.


Hepatitis B, Neutralization Assay, HBsAg, Chemiluminescence, Cut-off Index

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© The Author(s) 2024. Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License which permits unrestricted use, sharing, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.