Serologic testing of cornea donors.
OBJECTIVE
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.


CONCLUSIONS
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.
Glasser
D B
DB
Patuxent Medical Group, Columbia, Maryland 21045, USA.
D016039:Corneal Transplantation; D018562:Disease Transmission, Infectious / Q000331:legislation & jurisprudence / Q000517:prevention & control* / Q000706:statistics & numerical data; D005125:Eye Banks / Q000592:standards; D015818:Eye Infections, Bacterial / Q000175:diagnosis / Q000635:transmission*; D015828:Eye Infections, Viral / Q000175:diagnosis / Q000635:transmission*; D006801:Humans; D012698:Serologic Tests / Q000592:standards; D014019:Tissue Donors; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards