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

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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.

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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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Authors and Affiliations

  1. Puget Sound Blood Center/Northwest Tissue Center, 921 Terry Avenue Seattle, WA, 98104

    D. Michael Strong & Karen Nelson

  2. American Red Cross, St. Paul, MN

    Marge Pierce

  3. American Red Cross, Gaithersburg, MD

    Susan L. Stramer

Authors
  1. D. Michael Strong
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  2. Karen Nelson
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  3. Marge Pierce
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  4. Susan L. Stramer
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Correspondence to D. Michael Strong.

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Strong, D.M., Nelson, K., Pierce, M. et al. Preventing disease transmission by deceased tissue donors by testing blood for viral nucleic acid. Cell Tissue Banking 6, 255–262 (2005). https://doi.org/10.1007/s10561-005-2834-4

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  • DOI: https://doi.org/10.1007/s10561-005-2834-4

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