Author information
1
Division of Transplantation, Health Resources and Services Administration, Rockville, MD, USA.
2
US Food and Drug Administration, Silver Spring, MD, USA.
3
Virginia Office of the Chief Medical Examiner, Richmond, VA, USA.
4
Office of Biostatistics and Epidemiology, US Food and Drug Administration, Silver Spring, MD, USA.
Abstract
BACKGROUND:
Evaluation of assay performance on post-mortem blood specimens (obtained after cessation of the heartbeat) presents unique scientific and regulatory challenges. In the United States, assay performance is evaluated in part by spiking postmortem specimens.
METHODS:
Fifty-four specimens obtained from decedents known to be infected with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV), including some coinfections, were tested for each virus using Food and Drug Administration (FDA)-licensed donor screening tests for nucleic acid, antibody, and antigen.
RESULTS:
For each disease, >95% of subjects who were reported to have an infection at the time of death had a positive test result on at least one of the donor screening assays for that infection.
CONCLUSION:
Licensed donor screening tests were positive on postmortem specimens obtained within 24 hours of death from individuals dying with HIV, HCV, and/or HBV, and were able to detect presence of the virus. The use of multiple tests (including antibody and direct viral detection methods) is necessary to adequately evaluate donors.