This assay is not intended for use in screening blood, plasma or tissue donors.
Specimens from patients who have received preparations of mouse monoclonal antibodies for diagnosis or therapy may contain human anti-mouse antibodies (HAMA). Such specimens may show either falsely elevated or depressed values when tested with assay kits that employ mouse monoclonal antibodies.
A reactive HBsAg result does not exclude co-infection by another hepatitis virus.