Preventing disease transmission by deceased tissue donors by testing blood for viral nucleic acid
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Cell and Tissue Banking (2005) 6:255–262 DOI 10.1007/s10561-005-2834-4
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Preventing disease transmission by deceased tissue donors by testing blood for viral nucleic acid D. Michael Strong1,*, Karen Nelson1, Marge Pierce2 and Susan L. Stramer3 1
Puget Sound Blood Center/Northwest Tissue Center, 921 Terry Avenue Seattle, WA 98104; 2American Red Cross, St. Paul, MN; 3American Red Cross, Gaithersburg, MD; *Author for correspondence (e-mail: [email protected]; phone: +1-206-292-1889; fax: +1-206-292-8030)
Received 1 June 2005; accepted in revised form 15 August 2005
Key words: Deceased tissue donors, Infectious disease, NAT, Nucleic acid testing, Tissue transplantation
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. 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 – transcriptionmediated amplification
Introduction Testing of blood samples from deceased donors who may donate tissue has traditionally been carried out with immunoassays to detect viral antibodies or antigens. The assays that have been routinely employed have been those originally developed for the screening of potential blood donors. Viruses such as hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus type 1 (HIV) have all been transmitted by tissue transplantation (Conrad et al. 1995; Eastlund 1995; Homan et al. 2003; Eastlund and
Strong 2004). These viruses, which have also been transmitted by blood transfusion, have been difficult to detect in asymptomatic donors during the so-called viremic window period, before antibodies are detectable (Busch et al. 1995; Dodd 2000). Although window period estimates have been extensively studied for blood donors (Schreiber et al. 1996; Dodd et al. 2000; Glynn et al. 2000), similar estimates have only recently been made for tissue donors (Stanworth et al. 2000; Zou et al. 2004). As a result, it has been determined that the risk of a viremic tissue donor being in the window period with a negative test for HIV or HCV
256 antibodies is substantially higher th
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