Lab Med Qual Assur.  2024 Jun;46(2):103-108. 10.15263/jlmqa.2024.46.2.103.

Current Status of Hepatitis B Surface Antigen Neutralization Testing in Korea

• Park K
• Yoo SJ

• KMID: 2557225
• DOI: http://doi.org/10.15263/jlmqa.2024.46.2.103

Abstract

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 falsepositive results of HBsAg qualitative tests, especially for specimens with lower measurement values.

Keyword

False-positivity; Hepatitis B surface antigens; Neutralization