Need for Confirmatory Neutralization Tests for Hepatitis B Surface Antigen Tests in Populations with Intermediate Prevalence.

Abstract

OBJECTIVE:

Hepatitis B surface antigen (HBsAg) is known as the hallmark of hepatitis B virus (HBV) infection. This study aimed to determine whether an HBsAg neutralization test is necessary to accurately interpret HBsAg test results.

METHODS:

Initially reactive HBsAg specimens from a 5-year period, with cutoff index values between 1.0 and 2.0, were subjected to neutralization confirmatory testing using an Elecsys HBsAg Confirmatory test kit (Roche Diagnostics GmbH. Mannheim, Germany).

RESULTS:

The neutralization test showed 46.1% positive (confirmed positive group) and 53.9% negative (confirmed negative group) results from the total specimens. Among the confirmed negative group, 79.5% of patients were confirmed to be negative for the current infection, whereas 4 patients in the chronic hepatitis B subgroup showed a neutralization percentage close to 40%. More than half of patients in the confirmed positive group were considered to be in the hepatitis B e antigen-negative inactive HBsAg carrier phase.

CONCLUSION:

In populations with intermediate HBV prevalence, a neutralization test is necessary to confirm an HBsAg result and reduce the false positive and false negative rates of initial HBsAg tests.

• Authors: Min Young Lee, So Young Kang, Woo In Lee, Myeong Hee Kim
• Journal: Laboratory medicine (Lab Med) Vol. 52 Issue 5 Pg. 485-492 (Sep 01 2021) ISSN: 1943-7730 [Electronic] England
• PMID: 33629106 (Publication Type: Journal Article)
• Copyright: © American Society for Clinical Pathology, 2021. All rights reserved. For permissions, please e-mail: [email protected].

Chemical References

• Hepatitis B Surface Antigens

Topics

• Hepatitis B (diagnosis, epidemiology)
• Hepatitis B Surface Antigens
• Hepatitis B virus
• Humans
• Neutralization Tests
• Prevalence