Cell and Tissue Banking

, 6:255 | Cite as

Preventing disease transmission by deceased tissue donors by testing blood for viral nucleic acid

  • D. Michael Strong
  • Karen Nelson
  • Marge Pierce
  • Susan L. Stramer
Article

Abstract

Nucleic acid testing (NAT) has reduced the risk of transmitting infectious disease through blood transfusion. Currently NAT for HIV-1 and HCV are FDA licensed and performed by nearly all blood collection facilities, but HBV NAT is performed under an investigational study protocol. Residual risk estimates indicate that NAT could potentially reduce disease transmission through transplanted tissue. However, tissue donor samples obtained post-mortem have the potential to produce an invalid NAT result due to inhibition of amplification reactions by hemolysis and other factors. The studies reported here summarize the development of protocols to allow NAT of deceased donor samples with reduced rates of invalid results. Using these protocols, inventories from two tissue centers were tested with greater than 99% of samples producing a valid test result.

Keywords

Deceased tissue donors Infectious disease NAT Nucleic acid testing Tissue transplantation 

Abbreviations

HBV

hepatitis B virus

HCV

hepatitis C virus

HIV

human immunodeficiency virus

IC

internal control

IND

investigational new drug study protocol approved by the Food and Drug Administration

NAT

Nucleic acid testing

PCR

polymerase chain reaction

TMA

transcription-mediated amplification

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Copyright information

© Springer 2005

Authors and Affiliations

  • D. Michael Strong
    • 1
  • Karen Nelson
    • 1
  • Marge Pierce
    • 2
  • Susan L. Stramer
    • 3
  1. 1.Puget Sound Blood Center/Northwest Tissue Center
  2. 2.American Red CrossSt. Paul
  3. 3.American Red CrossGaithersburg

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