The proliferation of newly discovered pathogens and screening tests poses a growing dilemma for the eye-banking community: which of the multitude of serologic tests should be required to screen donors? Are there guidelines that can be developed to facilitate systematic evaluation of future screening proposals according to standards of medical appropriateness and cost effectiveness? What are the scientific data requirements for a successful evaluation program? Are there instances in which one could expect such evaluation to yield divergent recommendations for the screening of corneal tissue vs other organs/tissues?
This issue was most clearly brought into focus with the onset of the acquired immunodeficiency syndrome (AIDS) epidemic in the United States in 19811 and later reports of AIDS transmission via blood transfusion.2 By 1985, a serologic enzyme-linked immunosorbent assay (ELISA) to detect human immunodeficiency virus (HIV) antibodies was developed and licensed by the Food and Drug Administration (FDA).
Feigenbaum S, Pepose JS. Screening Corneal Donors for Transmissible Disease: Safety, Resources, and Reason. Arch Ophthalmol. 1991;109(7):941–943. doi:10.1001/archopht.1991.01080070053033
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