Mutation of the "a" determinant of HBsAg with discordant HBsAg diagnostic kits

Abstract

Sera from 1003 in- and out-patients were investigated for hepatitis B surface antigen (HBsAg) mutation at Siriraj Hospital, Bangkok, Thailand. Individual samples were screened using two commercial HBsAg kits on automatic machine-based assays set up in parallel. The first kit was a sandwich ELISA kit that used monoclonal capture/monoclonal conjugate and color detection whereas the second was a sandwich MEIA, using monoclonal capture/polyclonal indicator and fluorochrome determination. Six specimens were found discordant by negative EIA and positive MEIA; two specimens of which were detectable of HBV DNA. Three out of four discordant results were confirmed by an anti-HBs neutralization assay. Based on direct sequencing, one HBsAg/anti-HBs sample with multiple mutations in the S gene was found. The mutation included the common glycine to arginine escape mutation at amino acid position 145 of the "a" determinant. The observation should alert the blood bank to the necessity of using screening kits capable of detecting HBV mutant carriers as well as providing verification for the phenomenon of vaccine-escape mutation in Thailand.