Serologic testing of cornea donors

PURPOSE: To review the current requirements and rationale for serologic testing of cornea donors and to provide guidelines for dealing with results of nonrequired tests. METHODS: 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. RESULTS: 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. CONCLUSION: 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.