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Evaluation of serological screening of cadaveric sera for donor selection for cornea transplantation
1Institut für Virologie und Seuchenhygiene, Medizinische Hochschule Hannover, Germany. ahei@virologie.mh-hannover.de
Insights
Serological testing of cadaveric sera is unreliable for screening cornea donors. This method may not ensure virus safety for cornea grafts, necessitating alternative strategies like nucleic acid testing.
Area of Science:
- Ophthalmology
- Virology
- Transplantation Immunology
Background:
- Corneal transplantation is a common procedure, with donor tissue explanted up to 72 hours postmortem.
- Current cornea banking practices primarily rely on serological testing of postmortem serum to screen for infectious agents like HIV, HBV, and HCV.
- The reliability of postmortem serological testing for donor screening remains a critical concern for graft safety.
Purpose of the Study:
- To evaluate the accuracy of serological testing of cadaveric serum compared to premortem serum for infectious disease screening in potential cornea donors.
- To determine the impact of discordant results on the virus safety of cornea grafts.
- To assess the adequacy of current screening protocols in preventing viral transmission through corneal transplantation.
Main Methods:
- Paired premortem and cadaveric sera from 33 potential cornea donors were tested for antibodies to HIV, HBV (HBsAg), and HCV.
- Enzyme-linked immunosorbent assay (ELISA) was used for initial screening.
- Forensic DNA profiling using polymerase chain reaction (PCR) confirmed sample identity, and HCV antibody testing was further validated with HCV-RIBA strip immunoassay.
Main Results:
- Seventeen out of 33 donors (51.5%) showed discordant serological results between premortem and cadaveric samples.
- False-positive HBsAg ELISA results were frequent in cadaveric sera (16/33).
- One case demonstrated a false-negative HCV antibody result in cadaveric serum, posing a risk to graft virus safety.
Conclusions:
- Serological testing of cadaveric sera is not a reliable method for screening potential cornea donors.
- Current screening practices may not be sufficient to guarantee the virus safety of cornea grafts.
- Alternative screening strategies, such as molecular methods like PCR for viral nucleic acid detection, should be considered and evaluated.
Abstract:
Human corneas are explanted for grafting as late as 72 h after death, for example, from medical examiner cases. Currently, infection of the donor with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) is excluded in most cornea banks by serological testing of the cadaveric serum only. The reliability of this strategy was investigated by testing paired cadaveric and premortem sera of 33 potential donors. Results were discordant in 17 of 33 donors by at least one assay. Most frequently, HBsAg enzyme-linked immunosorbent assay (ELISA) yielded false-positive results with the cadaveric serum (16 of 33 serum pairs). Virus safety of the graft was affected in a single case, which was HCV antibody negative in the cadaveric serum, but positive in the premortem serum (confirmed by HCV-RIBA strip immunoassay). Forensic DNA profiling by polymerase chain reaction (PCR) of both serum samples confirmed that these were derived from the same individual. In conclusion, the results indicate that serological testing of cadaveric sera is not a reliable method for screening of potential cornea donors, and may not be sufficient for the virus safety of cornea grafts. Therefore, other screening strategies such as detection of viral nucleic acids by PCR should be evaluated.