Zuck T F, Sherwood W C, Bove J R
Transfusion. 1987 Mar-Apr;27(2):203-6. doi: 10.1046/j.1537-2995.1987.27287150202.x.
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.
美国食品药品监督管理局近期主办了一场研讨会，会上对有关用于输血的献血替代检测的数据进行了审查，目的是降低输血后非甲非乙型肝炎的风险。临床研究表明，检测丙氨酸转氨酶和乙肝核心抗原抗体（抗-HBc）的有效性是可以预测的，这表明此类检测会有帮助，不过最近一些使用抗-HBc检测的研究对其有效性提出了质疑。会上介绍了确定筛查检测临界值的不同方法，并讨论了检测标准化方面的困难。还考虑了美国替代筛查项目对献血者的法律、伦理和医学影响。本文还总结了一场由私营部门主办的会议，该会议有主要血库组织的代表参加，旨在讨论研讨会的议程以及对全国供血进行筛查的问题。
