Division of Transplantation, Health Resources and Services Administration, Rockville, MD, USA.
US Food and Drug Administration, Silver Spring, MD, USA.
Virginia Office of the Chief Medical Examiner, Richmond, VA, USA.
Office of Biostatistics and Epidemiology, US Food and Drug Administration, Silver Spring, MD, USA.
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.
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.
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.
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.