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Human immunodeficiency virus p24 antigen testing in cornea donors
C W Chung1, C J Rapuano, P R Laibson
1Cornea Service, Wills Eye Hospital, Philadelphia, Pennsylvania, USA.
Insights
P24 antigen testing for human immunodeficiency virus (HIV) in cornea donors can lead to unnecessary tissue waste and difficult clinical decisions. Current guidelines for non-required screening tests in eye banking need further clarification.
Area of Science:
- Ophthalmology
- Virology
- Transplantation Immunology
Background:
- P24 antigen testing can detect early human immunodeficiency virus (HIV) infection but may yield false positives in cadaveric specimens.
- While not mandated by regulatory bodies, some tissue banks perform p24 testing on cornea donors, impacting eye banking practices.
Observation:
- Two corneal transplants were affected by delayed p24 reactivity results from other tissue banks.
- One recipient required a repeat corneal transplant due to a p24 reactivity report, though subsequent PCR testing was negative.
- Another case lacked sufficient specimen for confirmatory testing, with the recipient remaining seronegative for HIV.
Findings:
- The Lions Eye Bank of Delaware Valley initiated p24 and other non-required tests, leading to the discard of 22 corneas (11 donors) over two months due to reactive results.
- Reactive p24 tests led to discarding 4 donors, while 6 donors were reactive for hepatitis B core antibody, and 1 for syphilis.
Implications:
- Delayed reporting of p24 assay results can create challenging clinical scenarios post-transplantation.
- Implementing p24 testing for cornea donors may result in significant wastage of viable donor tissue.
- There is a need for clearer guidance on managing positive results from p24 and other non-required screening tests in eye banking.
Purpose:
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.
Methods:
Two clinical cases and records from the Lions Eye Bank of Delaware Valley (LEBDV) were reviewed retrospectively.
Results:
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.
Conclusions:
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.
