Korean J Lab Med.  2010 Apr;30(2):178-184. 10.3343/kjlm.2010.30.2.178.

Comparison of Nine Different Qualitative HBsAg Assay Kits

• Yang J
• Kim JH
• Kim Y

• KMID: 1096805
• DOI: http://doi.org/10.3343/kjlm.2010.30.2.178

Abstract

BACKGROUND
Qualitative hepatitis B surface antigen (HBsAg) assay kits are still commonly used in Korea where hepatitis B virus (HBV) infection is endemic. The accurate determination of HBsAg plays a crucial role in the diagnosis and prevention of HBV infection, especially in endemic areas. The aim of this study was to compare the detection sensitivities of 9 qualitative HBsAg assay kits.
METHODS
Seven pooled sera with HBsAg concentration ranging from 0.14 IU/mL to 29.96 IU/mL were prepared. The HBsAg concentration of each pooled serum was determined by a quantitative HBsAg assay, Architect HBsAg (Abbott Laboratories, Ireland). The fully automated immunoassay kits included Elecsys HBsAg (Roche Diagnostics, Germany) and Immulite 2000 HBsAg (DPC, USA) and the rapid tests included 5 immunochromatographic assay (ICA) kits and 2 reverse passive hemagglutination assay (RPHA) kits.
RESULTS
Elecsys HBsAg (Roche Diagnostics) showed positive result in pooled serum with HBsAg concentration of 0.14 IU/mL, but Immulite 2000 HBsAg (DPC) showed negative result in the same concentration. Although ICA kits showed variable results among different assay kits, all of them showed negative results in pooled sera with HBsAg concentration of < or =1.89 IU/mL. Two RPHA kits showed negative results in pooled sera with HBsAg concentration of < or =7.98 IU/mL.
CONCLUSIONS
Although ICAs were more sensitive than RPHAs, they had variable sensitivities for HBsAg and were less sensitive than the automated immunoassay kits. Therefore, ICAs and RPHAs should be used with caution in the screening tests for HBsAg and their sensitivities need to be improved.

Keyword

HBsAg; Immunochromatographic assay; Reverse passive hemagglutination assay

MeSH Terms

Chemiluminescent Measurements
Electrochemical Techniques
Enzyme-Linked Immunosorbent Assay
Genotype
Hemagglutination Tests
Hepatitis B/*diagnosis
Hepatitis B Surface Antigens/*blood
Humans
Reagent Kits, Diagnostic