NAT Update; Where are We Today?

  • Susan L. Stramer
Part of the Developments in Hematology and Immunology book series (DIHI, volume 37)


A recent review covered the one-year experience with NAT in North America [1]. In that review, five different programs including testing with two different manufacturers of NAT assays for both HIV-1 and HCV were discussed. When combined, the HCV yield for 16 3 million donations tested was 62 confirmed positives (1:263,000); the HIV-1 yield for 12.6 million donations tested was 6 (1:2,100,000). Two of the six HIV-1 NAT positives were also HIV-1 p24 antigen (Ag) reactive; excluding those donors that were already detected by an FDA licensed screening test for p24 Ag reduced yield to 1:3,150,000. Updating these numbers for two years of screening increases the number of yield samples for HCV to 113 per 29,253,815 donations screened (1:259,000) and for HIV-1, including HIV-1 p24 Ag reactives, to 8 per 26,339,192 donations screened (1:3,292,400). Excluding the two HIV-1 p24 Ag reactives reduces the HIV-1 NAT yield to 6 (1:4,390,000). The updated numbers for the two-year experience are shown in Tables 1 and 2. Variability observed by site for HCV NAT yield is influenced greatly by the HCV antibody-screening test used. For sites using HCV 2.0, their yield is approximately 1:150,000 whereas sites using HCV 3.0 have yields that range from 1:300,000 to 1:500,000 (March 2001, FDA Blood Products Advisory Committee, BPAC, Meeting).


Viral Load High Viral Load Residual Risk Window Period Nucleic Acid Testing 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    Stramer SL, Caglioti S, Strong DM. NAT of the United States and Canadian blood supply. Transfusion 2000; 40: 1165–68.PubMedCrossRefGoogle Scholar
  2. 2.
    Stramer SL, Porter RA, Brodsky JP, et al. Replacement of HIV-1 p24 antigen screening with HIV-1 RNA nucleic acid testing (NAT) for whole blood donations. Transfusion 1999; 39: 10S.Google Scholar
  3. 3.
    Kleinman S, Busch MP, Hall L, et al. False-positive HIV-1 test results in a low-risk screening setting of voluntary blood donation. JAMA 1998; 280: 1080–85.PubMedCrossRefGoogle Scholar
  4. 4.
    Peoples BG, Preston SB, Tzeng JL, et al. Prolonged antibody-negative HCV viremia in a US blood donor with apparent HCV transmission to a recipient. Transfusion 2000; 40: 1280–81.PubMedCrossRefGoogle Scholar
  5. 5.
    Lau JYN, Mizokami M, Kolberg JA, et al. Application of six hepatitis C virus gentotyping systems to sera from chronic hepatitis C patients in the United States. J Infect Dis 1995; 171: 281–89.PubMedCrossRefGoogle Scholar
  6. 6.
    Zein NN, Persing DH, Hepatitis C genotypes: Current trends and future implications. Mayo Clin Proc 1996; 71: 458–62.PubMedCrossRefGoogle Scholar
  7. 7.
    Alter HJ, Seeff LB. Recovery, persistance, and sequelae in HCV infection: A perspective on long-term outcome. Semin Liver Dis 2001; 20: 17–35.Google Scholar
  8. 8.
    Seeff LB. Why is there such difficulty in defining the natural history of hepatitis C? Transfusion 2000; 40: 1161–64.PubMedCrossRefGoogle Scholar
  9. 9.
    Stramer SL, Brodsky JP, Peoples BG, et al. Relationship of nucleic acid testing (NAT) results to HIV and HCV serology among donors; relevance to counseling. Transfusion 2000; 40: 115S.Google Scholar
  10. 10.
    Strainer SL, Kleinman SH, Busch MP. Rate of HIV antibody false positive western blots (WB) and correlation with WB banding pattern. Transfusion 1997; 37: 1S.Google Scholar
  11. 11.
    Schreiber, GB, Busch, MP, Kleinman, SH, Korelitz, JJ. The risk of transfusion-transmitted viral infections. The Retrovirus Epidemiology Donor Study. N Engl J Med 1996; 334: 1685–90.PubMedCrossRefGoogle Scholar
  12. 12.
    Kleinman SH, Busch MP, Korelitz JJ, et al. The incidence/window period model and its use to assess the risk of transfusion-transmitted human immunodeficiency virus and hepatitis C virus infection. Trans Med Rev 1997; 11: 155–72.CrossRefGoogle Scholar
  13. 13.
    Stramer SL, Porter R, Brodsky JP. Sensitivity of HIV and HCV RNA by pooled genome amplification testing (GAT). Transfusion 1998; 38: 70S.Google Scholar
  14. 14.
    Busch MP, Korelitz JJ, Kleinman SH, et al. Declining value of alanine aminotransferase in screening of blood donors to prevent posttransfusion hepatitis B and C virus infection. The Retrovirus Epidemiology Donor Study. Transfusion 1995; 35: 903–10.PubMedCrossRefGoogle Scholar
  15. 15.
    Aberle-Grasse JM, Dodd RY, Stramer SL. Recent trends in seroprevalence and incidence of HIV-1/2, HCV, and HBV in US allogeneic blood donors. Transfusion 2000; 40: 5S.Google Scholar
  16. 16.
    Dodd RY, Aberle-Grasse JM, Stramer SL. The yield of nucleic acid testing (NAT) for HIV and HCV RNA in a population of US voluntary donors: relationship to contemporary measures of incidence. Transfusion 2000; 40: 1 P.CrossRefGoogle Scholar
  17. 17.
    Jackson BR, Busch MP, Strainer SL. The cost-effectiveness of nucleic acid testing for HIV, hepatitis C virus and hepatitis B virus in whole blood donations. Submitted for publication.Google Scholar
  18. 18.
    Busch MP, Dodd RY. NAT and blood safety: what is the paradigm? Transfusion 200; 40: 1157–60.Google Scholar
  19. 19.
    Busch MP, Kleinman SH, Jackson B, et al. Committee report. Nucleic acid amplification testing of blood donors for transfusion-transmitted infectious diseases: Report of the interorganizational task force on nucleic acid amplification testing of blood donors. Transfusion 2000; 40: 143–59.PubMedCrossRefGoogle Scholar
  20. 20.
    Roth W, Weber M, Seifried E. Feasibility and efficacy of routine PCR screening of blood donations for hepatitis C virus, hepatitis B virus, and HIV-1 in a blood-bank setting. Lancet 1999; 353: 359–63.PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media Dordrecht 2002

Authors and Affiliations

  • Susan L. Stramer
    • 1
  1. 1.National Testing and Reference Laboratories and Blood Services American Red CrossGaithersburgUSA

Personalised recommendations