Sensitivities of Four New Commercial Hepatitis B Virus Surface Antigen (HBsAg) Assays in Detection of HBsAg Mutant Forms

Detection of Highly Prevalent Hepatitis B Virus Coinfection among HIV-Seropositive Persons in Ghana

“…Previous studies indicated overall good performance of commercial assays with genotype E samples (31,32,43) but also suggested that amino acid changes within and outside the "a" determinant may affect HBsAg recognition (37). The performance of the three reference assays in this study was overall consistent with that reported by previous studies using European or reference samples (27,32,43). However, we identified a significant impact of the T123A mutation on the performance of the Architect assay.…”

“…Mutations in this region can affect anti-HBsAb binding and cause discrepant reactivity between diagnostic assays that employ different reagent configurations, reducing or abrogating the sensitivity of detection (1,9,11,20,22,28,53). While the glycine-to-arginine G145R substitution is the predominant HBsAg immune escape variant described in the literature (9, 53), a wide range of other mutants have also been described (1,21,27,33,44,49,52). Genotype E shows approximately 8% amino acid divergence from genotype A, which is commonly used as the reference virus type for the development of HBsAg diagnostic assays (35).…”

An Overview of Hepatitis B Virus Surface Antigen Mutant in the Asia Pacific

“…On the other hand, mutations outside the ''a'' determinant region are located primarily at positions 120 and 123. The Pro at position 120 can mutate to Gly/Thr/Ser/Asn/Gln (Jolivet-Reynaud et al, 2001), and mutation at position 123 gives rise to T123N, which is responsible for both diagnostic and HBIg therapeutic failure (Ly et al, 2006).…”

PHS Guideline for Reducing Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Transmission through Organ Transplantation

“…Test sensitivity and specificity were calculated in five analytic and three clinical studies, with a sensitivity of 100.0% [154][155][156][157][158][159][160] and a specificity range of 82.5%-100.0%. 36,[154][155][156][158][159][160][161][162] Five studies reported differences in window period time from third-generation Ab and polymerase chain reaction (PCR) assays using seroconversion 292  PHS Guideline Public Health Reports / July-August 2013 / Volume 128 panels.…”