Human immunodeficiency virus p24 antigen testing in cornea donors.

Abstract

Testing for the p24 antigen of the human immunodeficiency virus (HIV) may detect early HIV infection in the seronegative window; however, falsely reactive results may occur in cadaver specimens. Although neither the Food and Drug Administration (FDA) nor the Eye Bank Association of America requires p24 testing of cornea donors, many tissue banks using other organs from cornea donors do perform this assay, and the FDA requires that eye banks reject corneal tissue if a reactive p24 assay is reported. We investigated the impact of p24 testing on eye banking and corneal transplantation. Two clinical cases and records from the Lions Eye Bank of Delaware Valley (LEBDV) were reviewed retrospectively. Two corneas from the LEBDV were transplanted before the reporting of p24 reactivity by other tissue banks. In one case, because of the young age of the recipient, the surgeon elected to replace the cornea with new tissue hours after the original transplant, and later polymerase chain reaction (PCR) testing was negative. In the other case, there was not enough specimen to perform Western blot or PCR confirmatory testing. The patient was followed with periodic serologic testing for HIV and has remained seronegative. To avoid such problems in the future, the LEBDV initiated testing of all donors with p24 and other nonrequired screening tests. Over a 2-month period, 22 corneas (from 11 donors) were discarded because of these tests: 4 donors had reactive p24 tests, 6 were reactive for antibody to hepatitis B core antigen, and 1 had a reactive syphilis test. Results from p24 assays by other tissue banks may cause difficult clinical situations when the results are received after transplantation of the tissue, but the use of the p24 assay in the screening of cornea donors may result in excessive waste of donor tissue. Further guidance is needed regarding the management of positive results from this and other nonrequired screening tests.