• Sitemap
  • Contact Us

pISSN 2950-9114 eISSN 2950-9122
Article View

Original Article

Lab Med Qual Assur 2024; 46(2): 103-108

Published online June 30, 2024


Copyright © Korean Association of External Quality Assessment Service.

Current Status of Hepatitis B Surface Antigen Neutralization Testing in Korea

Kuenyoul Park and Soo Jin Yoo

Department of Laboratory Medicine, Sanggye Paik Hospital, School of Medicine, Inje University, Seoul, Korea

Correspondence to:Soo Jin Yoo
Department of Laboratory Medicine, Inje University Sanggye Paik Hospital, College of Medicine, Inje University, 1342 Dongil-ro, Nowon-gu, Seoul 01757, Korea
Tel +82-2-950-1242
E-mail sjyoo@paik.ac.kr

Received: December 27, 2023; Revised: February 20, 2024; Accepted: March 13, 2024

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.


Background: Neutralization testing to confirm hepatitis B surface antigen (HBsAg) positivity is strongly recommended to avoid false-positive results but was not reimbursed in Korea at that time of the study. This study aimed to investigate the status of neutralization testing for the confirmation of an HBsAg test result in Korea.
Methods: The manufacturers of HBsAg qualitative reagents were listed based on the proficiency test report of the Korean Association of External Quality Assessment Service. The supply status of neutralization reagents and their user laboratories were investigated. The laboratories using neutralization reagents were surveyed to determine the number of specimens utilized for HBsAg qualitative testing and subsequent neutralization testing. Their results were categorized according to the HBsAg levels measured in 2022.
Results: Seventeen laboratories performed HBsAg neutralization testing using Roche (14 sites) and Abbott (3 sites) reagents. Each laboratory applied a neutralizing agent to some HBsAg-positive samples using different cutoff points based on the instrument’s measurement values. In 14 laboratories using Roche neutralization reagents, 53.6% of the specimens were positive for HBsAg on neutralization test, of which 94.1% had a cutoff index of <10.
Conclusions: HBsAg neutralization testing is crucial for preventing false-positive results of HBsAg qualitative tests, especially for specimens with lower measurement values.

Keywords: False-positivity, Hepatitis B surface antigens, Neutralization

Supplementary File

Share this article on :

Stats or metrics