Detection of HIV-1 and HCV infections among antibody-negative blood donors by nucleic acid-amplification testing

New England Journal of Medicine

Volumn 351, Issue 8, 2004, Pages 760-768+842

  Stramer, Susan L ^a   Glynn, Simone A ^b   Kleinman, Steven H ^b,c   Strong, D Michael ^d   Caglioti, Sally ^e   Wright, David J ^b   Dodd, Roger Y ^a   Busch, Michael P ^e,f,g  

^a AMERICAN RED CROSS   (United States)

^b WESTAT   (United States)

^c UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^d PUGET SOUND BLOOD CENTER   (United States)

^e Blood Systems Laboratories   (United States)

^f Blood Centers of the Pacific   (United States)

^g UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIGEN P24; HUMAN IMMUNODEFICIENCY VIRUS ANTIBODY; VIRUS RNA;

ANTIBODY SCREENING; ARTICLE; BLOOD TRANSFUSION; CONTROLLED STUDY; FOLLOW UP; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFECTION RATE; INFECTION RISK; NONHUMAN; NUCLEIC ACID AMPLIFICATION; PRIORITY JOURNAL; SCREENING TEST; SEROCONVERSION; UNITED STATES; VIREMIA;

ALANINE TRANSAMINASE; BLOOD DONORS; HEPACIVIRUS; HEPATITIS C; HEPATITIS C ANTIBODIES; HIV ANTIBODIES; HIV INFECTIONS; HIV-1; HUMANS; NUCLEIC ACID AMPLIFICATION TECHNIQUES; RNA, VIRAL; VIREMIA;

EID: 4143071570     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJMoa040085     Document Type: Article

References (38)

1. 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.
2. Stramer SL, Caglioti S, Strong DM. NAT of the United States and Canadian blood supply. Transfusion 2000;40:1165-8. [Erratum, Transfusion 2001;41:1079.]
3. Stramer SL, Caglioti S, Strong DM. NAT of the United States and Canadian blood supply. Transfusion 2000;40:1165-8. [Erratum, Transfusion 2001;41:1079.]
4. Busch MP, Dodd RY. NAT and blood safety: what is the paradigm? Transfusion 2000;40:1157-60.
5. Busch MP. Closing the windows on viral transmission by blood transfusion. In: Stramer SL, ed. Blood safety in the new millennium. Bethesda, Md.: AABB Press, 2001:33-54.
6. Busch MP, Kleinman SH, Nemo GJ. Current and emerging infectious risks of blood transfusions. JAMA 2003;289:959-62.
7. Chamberland ME. Emerging infectious agents: do they pose a risk to the safety of transfused blood and blood products? Clin Infect Dis 2002;34:797-805.
8. Feibig EW, Wright DJ, Rawal BD, et al. Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection. AIDS 2003;17:1871-9.
9. Busch MP. Insights into the epidemiology, natural history and pathogenesis of hepatitis C virus infection from studies of infected donors and blood product recipients. Transfus Clin Biol 2001;8:200-6.
10. Galel SA, Strong DM, Tegtmeier GE, et al. Comparative yield of HCV RNA testing in blood donors screened by 2.0 versus 3.0 antibody assays. Transfusion 2002;42: 1507-13.
11. Peoples BG, Preston SB, Tzeng JL, Stramer SL, Gifford L, Wissel ME. Prolonged antibody-negative HCV viremia in a US blood donor with apparent HCV transmission to a recipient. Transfusion 2000;40:1280-1.
12. Busch MP, Stramer SL. The efficiency of HIV p24 antigen screening of US blood donors: projections versus reality. Infusionther Transfusionmed 1998;25:194-7.
13. Tobler LH, Busch MP. History of post-transfusion hepatitis. Clin Chem 1997;43: 1487-93.
14. Grant PR, Busch MP. Nucleic acid amplification technology methods used in blood donor screening. Transfus Med 2002;12: 229-42.
15. Giaehetti C, Linnen JM, Kolk DP, et al. Highly sensitive multiplex assay for detection of human immunodeficiency virus type 1 and hepatitis C virus RNA. J Clin Microbiol 2002;40:2408-19.
16. Dodd RY, Notari EP IV, Stramer SL. Current prevalence and incidence of infectious disease markers and estimated window-period risk in the American Red Cross blood donor population. Transfusion 2002; 42:975-9.
17. Confidence regions: definition and construction in the binomial case. In: Pratt JW, Gibbons JD. Concepts of nonparametric theory. New York: Springer-Verlag, 1981: 41-4.
18. Lehmann EL. Testing statistical hypotheses. New York: John Wiley, 1959:140-3.
19. Tobler LH, Stramer SL, Lee SR, et al. Impact of HCV 3.0 EIA relative to HCV 2.0 EIA on blood-donor sereening. Transfusion 2003;43:1452-9.
20. Marshall DA, Kleinman SH, Wong JB, et al. Cost-effectiveness of nucleic acid test screening of volunteer blood donations for hepatitis B, hepatitis C and human immunodeficiency virus in the United States. Vox Sang 2004;86:28-40.
21. National Blood Data Resource Center. 2002 Nationwide Blood Collection and Utilization Survey. Bethesda Md.: American Association of Blood Banks, 2003.
22. Schreiber GB, Busch MP, Kleinman SH, Korelitz JJ. The risk of transfusion-transmitred viral infections. N Engl J Med 1996;334: 1685-90.
23. Delwart EL, Kalmin ND, Jones TS, et al. First report of human immunodeficiency virus transmission via an RNA-screened blood donation. Vox Sang 2004;86:171-7.
24. 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:Suppl 10S:2s. abstract.
25. Schreiber GB, Glynn SA, Satten GA, et al. HIV seroconverting donors delay their return: screening test implications. Transfusion 2002;42:414-21.
26. Notari EP IV, Orton SL, Cable RG, et al. Seroprevalence of known and putative hepatitis markers in United States blood donors with ALT levels at least 120 IU per L. Transfusion 2001;41:751-5.
27. Janssen RS, Satten GA, Stramer SL, et al. New testing strategy to detect early HIV-1 infection for use in incidence estimates and for clinical and prevention purposes. JAMA 1998;280:42-8. [Erratum, JAMA 1999;281: 1893.]
28. Janssen RS, Satten GA, Stramer SL, et al. New testing strategy to detect early HIV-1 infection for use in incidence estimates and for clinical and prevention purposes. JAMA 1998;280:42-8. [Erratum, JAMA 1999;281: 1893.]
29. Orton SL, Stramer SL, Dodd RY, Alter MJ. Risk factors for HCV infection among blood donors confirmed to be positive for the presence of HCV RNA and not reactive for the presence of anti-HCV. Transfusion 2004;44:275-81.
30. Orland JR, Wright TL, Cooper S. Acute hepatitis C. Hepatology 2001;33:321-7.
31. Beld M, Penning M, van Putten M, et al. Low levels of hepatitis C virus RNA in serum, plasma, and peripheral blood mononuclear cells of injecting drug users during long antibody-undetectable periods before seroconversion. Blood 1999;94:1183-91.
32. Maple PA, McKee T, Desselberger U, Wreghitt TG. Hepatitis C virus infections in transplant patients: serological and virological investigations. J Med Virol 1994;44:43-8.
33. Schmidt WN, Wu P, Cederna J, Mitros FA, LaBrecque DR, Stapleton JT. Surreptitious hepatitis C virus (HCV) infection detected in the majority of patients with cryptogenic chronic hepatitis and negative HCV antibody tests. J Infect Dis 1997;176:27-33.
34. Alter MJ, Kuhnert WL, Finelli L. Guidelines for laboratory testing and result reporting of antibody to hepatitis C virus. MMWR Recomm Rep 2003;52(RR-3):1-13.
35. Pealer LN, Marfin AA, Petersen LR, et al. Transmission of West Nile virus through blood transfusion in the United States in 2002. N Engl J Med 2003;349:1236-45.
36. Dodd RY. Emerging infections, transfusion safety, and epidemiology. N Engl J Med 2003;349:1205-6.
37. Update: West Nile virus screening of blood donations and transfusion-associated transmission - United States, 2003. MMWR Morb Mortal Wldy Rep 2004;53: 281-4.
38. Jackson BR, Busch MP, Stramer SL, AuBuchon JP. The cost-effectiveness of NAT for HIV, HCV, and HBV in whole-blood donations. Transfusion 2003;43:721-9.