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- Title
Need for Confirmatory Neutralization Tests for Hepatitis B Surface Antigen Tests in Populations with Intermediate Prevalence.
- Authors
Lee, Min Young; Kang, So Young; Lee, Woo In; Kim, Myeong Hee
- 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.
- Subjects
ANTIGEN analysis; HEPATITIS B; ACQUISITION of data methodology; SERODIAGNOSIS; NEUTRALIZATION tests; MEDICAL records; DESCRIPTIVE statistics; CHI-squared test; DIAGNOSTIC errors; DATA analysis software
- Publication
Laboratory Medicine, 2021, Vol 52, Issue 5, p485
- ISSN
0007-5027
- Publication type
Article
- DOI
10.1093/labmed/lmab006