Infectious disease screening of blood specimens collected post-mortem provides comparable results to pre-mortem specimens
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Serology assays for standard screening are optimised for use with sera collected from living adults and children. Because of potential changes in the vascular compartments after death, methods used for screening sera from cadaveric organ donors need to be validated before testing these specimens. Serum was separated from blood collected from cadaveric donors within 24 h of death and biochemical parameters measured to detect dilution of protein and haemolysis. In order to demonstrate if any inhibitors that might interfere with the assays were present, pre and post-mortem specimens were spiked with aliquots of human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), human T-cell Lymphotropic Virus (HTLV) and T. pallidum-positive sera. Comparison of serum from living subjects with serum obtained post-mortem showed that while the concentration of total protein decreased, concentrations of albumin, immunoglobulin G (IgG) and immunoglobulin M (IgM) remained unchanged. The degree of haemolysis, as measured by free haemoglobin, was within the limits accepted for the Architect analyser. Spiking of pre- and post-mortem specimens with aliquots of HIV, HCV, HBV, HTLV and T. pallidum-positive sera showed no statistical difference in the signal between pre-mortem and post-mortem results when tested on the Abbott Architect analyser. Positive results were obtained in each of a further nine subjects who had tested positive for HIV (n = 1), HCV (n = 8), HBV (n = 1) on pre-mortem serological testing. These findings suggest that the sensitivity of the Abbott Architect serological screening tests is not significantly affected in specimens collected within 24 h of the cessation of life.
KeywordsDonor Screening Post-mortem Blood Virology
Financial support for this work was provided by New South Wales Department of Health.
- Eastlund T, Schuller R (1994) The effect of hemodilution on detectability of anti-HIV, anti-HCV and HBsAg: an in vitro study. Paper presented at: Proceedings of the 18th annual meeting, American Association of Tissue Banks (San Francisco)Google Scholar
- Food and Drug Administration (2004) Guidance for industry. Recommendations for obtaining a labeling claim for communicable disease donor screening tests using cadavericblood specimens from donors of human cells, tissues and cellular and tissue-based products (HCT/Ps), pp 1–7. http://wwwfdagov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm073972htm
- Kitchen AD, Newham JA (2010) Qualification of serological infectious disease assays for the screening of samples from deceased tissue donors. Cell Tissue Bank. doi: 10.1007/s10561-010-9175-7
- NHMRC (2007). Organ and tissue donation after death, for transplantation: guidelines for ethical practice for health professionals. Australian Government, CanberraGoogle Scholar
- Therapeutic Goods Administration (2000a). Australian code of good manufacturing practice—human blood and tissues, section 827. Australian Government Department of Health and AgeingGoogle Scholar
- Therapeutic Goods Administration (2000b) Australian code of good manufacturing practice—human blood and tissues. p. 26 (point 835)Google Scholar