A review of recent events related to surrogate testing of blood to prevent non-A, non-B posttransfusion hepatitis

Abstract

A workshop sponsored by the Food and Drug Administration was held recently during which available data were reviewed concerning surrogate testing of blood donated for transfusion in order to reduce the risks of posttransfusion non-A, non-B hepatitis. Clinical studies from which the efficacy of testing for alanine aminotransferase and antibody to hepatitis B core antigen (anti-HBc) could be predicted indicated such testing would be useful, although several studies using tests for anti-HBc developed recently questioned their effectiveness. Different approaches to establishing the cut-off values for the screening tests were presented and difficulties regarding test standardization were discussed. The legal, ethical, and medical implications for donors of surrogate screening programs in the United States also were considered. A meeting sponsored by the private sector that included representatives of the major blood banking organizations and was convened to discuss the workshop proceedings and nationwide screening of the blood supply also is summarized.