title: [Comparison of nine different qualitative HBsAg assay kits].
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.
authors.affiliation: Department of Laboratory Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.
authors.forename: Jinyoung
authors.initials: J
authors.lastname: Yang
authors.forename: Jong Hyun
authors.initials: JH
authors.lastname: Kim
authors.forename: Yeongsic
authors.initials: Y
authors.lastname: Kim
mesh_terms: D055664:Electrochemical Techniques; D004797:Enzyme-Linked Immunosorbent Assay; D005838:Genotype; D006386:Hemagglutination Tests; D006509:Hepatitis B / Q000175:diagnosis*; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D006801:Humans; D008163:Luminescent Measurements; D011933:Reagent Kits, Diagnostic
chemical_list: D006514:Hepatitis B Surface Antigens; D011933:Reagent Kits, Diagnostic