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Abstract
HBV surface antigen (HBsAg) is the most important marker for the laboratory diagnosis of hepatitis B virus infection. Mutants can emerge in patients as result of selective pressure. Since almost all diagnostic assays for detection of HBsAg rely on antibodies against the major epitope a determinant, amino acid (aa) substitutions in this region could potentially lead to diagnostic failures. The new generation of HBsAg assays uses mixtures of monoclonal antibodies in order to recognize the known S gene mutants and ideally should be sensitive enough to detect the smallest amounts of HBsAg present in low-level carriers.
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