Glasser D B
Patuxent Medical Group, Columbia, Maryland 21045, USA.
Cornea. 1998 Mar;17(2):123-8. doi: 10.1097/00003226-199803000-00001.
To review the current requirements and rationale for serologic testing of cornea donors and to provide guidelines for dealing with results of nonrequired tests.
Eye Bank Association of America (EBAA) and Food and Drug Administration (FDA) regulations are examined with respect to current knowledge of the risk of donor-to-host transmission of systemic infectious diseases via corneal transplantation.
Negative screening tests are required for human immunodeficiency virus (HIV) 1 and 2, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) before release of tissue for transplantation. Other tests reported by organ-procurement organizations commonly include hepatitis B core antibody (anti-HBc), syphilis, cytomegalovirus (CMV), and human T-lymphotropic virus (HTLV) I and II. No systemic infectious-disease transmission from donor corneas supplied by EBAA-member eye banks has occurred in the last 12 years, a period during which >400,000 corneas were provided for transplantation.
EBAA donor-screening requirements, including serologic testing, have resulted in an excellent safety record. Requirements for serologic testing should continue to be regularly reviewed as new information becomes available.
回顾目前角膜供体血清学检测的要求及基本原理,并为处理非必需检测结果提供指导原则。
根据目前关于通过角膜移植进行供体到宿主系统性传染病传播风险的认识,对美国眼库协会(EBAA)和食品药品监督管理局(FDA)的相关规定进行审查。
在组织用于移植前,需要对人类免疫缺陷病毒(HIV)1型和2型、乙型肝炎表面抗原(HBsAg)以及丙型肝炎病毒(HCV)进行阴性筛查检测。器官采购组织报告的其他检测通常包括乙型肝炎核心抗体(抗-HBc)、梅毒、巨细胞病毒(CMV)以及人类嗜T淋巴细胞病毒(HTLV)I型和II型。在过去12年中,EBAA成员眼库提供的供体角膜未发生系统性传染病传播,在此期间有超过40万片角膜用于移植。
包括血清学检测在内的EBAA供体筛查要求已取得出色的安全记录。随着新信息的出现,应继续定期审查血清学检测要求。