Early detection of hepatitis B surface antigen and detection of HBsAg mutants: a comparison of five assays

Vox Sang. 2001 Nov;81(4):219-21. doi: 10.1046/j.1423-0410.2001.00110.x.


Background and objectives: Assays for the detection of hepatitis B surface antigen (HBsAg) face two challenges: the emergence of sensitive techniques for detection of hepatitis B virus DNA and the existence of HBsAg mutant hepatitis B viruses. We studied the sensitivity of five modern assays for detection of HBsAg.

Materials and methods: The sensitivity of two mini robot-based assays--IMx HBsAg V2 and Vidas HBsAg--and three enzyme-linked immunosorbent assays (ELISAs) with microtitre plate format--Hepanostika Uni-Form II v1.2, Monolisa Ag HBs Plus and HBsAg Test System 3--was compared testing 11 HBsAg seroconversion series, serial dilutions prepared from three HBsAg standards and nine HBsAg mutant samples.

Results and conclusion: Overall, the IMx HBsAg V2 assay showed the highest sensitivity. It outperformed the Vidas HBsAg in analytical sensitivity and in detection of HBsAg mutants. Among the microtitre plate ELISAs, the Monolisa Ag HBs Plus outperformed the HBsAg Test System 3 in detection of HBsAg mutants and it surpassed the Hepanostika Uni-Form II v1.2 in analytical sensitivity.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Diagnostic Equipment / standards
  • Enzyme-Linked Immunosorbent Assay / instrumentation
  • Enzyme-Linked Immunosorbent Assay / methods
  • Enzyme-Linked Immunosorbent Assay / standards
  • Hepatitis B / diagnosis*
  • Hepatitis B / immunology
  • Hepatitis B Surface Antigens / analysis*
  • Hepatitis B Surface Antigens / genetics
  • Humans
  • Mutation*
  • Reagent Kits, Diagnostic / standards
  • Reference Standards
  • Robotics
  • Sensitivity and Specificity
  • Serologic Tests / instrumentation
  • Serologic Tests / methods
  • Serologic Tests / standards


  • Hepatitis B Surface Antigens
  • Reagent Kits, Diagnostic