Articlebronze2004

Detection of HIV-1 and HCV Infections among Antibody-Negative Blood Donors by Nucleic Acid–Amplification Testing

Susan L. Stramer · Simone A. Glynn · Steven H Kleinman · Douglas Michael Strong · Sally Caglioti · David J. Wright +2 more

535 citations0/0 files storedNew England Journal of Medicine

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Blood donation and transfusion practices HIV Research and Treatment Hepatitis C virus research

Abstract

BACKGROUND: Testing of blood donors for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) RNA by means of nucleic acid amplification was introduced in the United States as an investigational screening test in mid-1999 to identify donations made during the window period before seroconversion. METHODS: We analyzed all antibody-nonreactive donations that were confirmed to be positive for HIV-1 and HCV RNA on nucleic acid-amplification testing of "minipools" (pools of 16 to 24 donations) by the main blood-collection programs in the United States during the first three years of nucleic acid screening. RESULTS: Among 37,164,054 units screened, 12 were confirmed to be positive for HIV-1 RNA--or 1 in 3.1 million donations--only 2 of which were detected by HIV-1 p24 antigen testing. For HCV, of 39,721,404 units screened, 170 were confirmed to be positive for HCV RNA, or 1 in 230,000 donations (or 1 in 270,000 on the basis of 139 donations confirmed to be positive for HCV RNA with the use of a more sensitive HCV-antibody test). The respective rates of positive HCV and HIV-1 nucleic acid-amplification tests were 3.3 and 4.1 times as high among first-time donors as among donors who gave blood repeatedly. Follow-up studies of 67 HCV RNA-positive donors demonstrated that seroconversion occurred a median of 35 days after the index donation, followed by a low rate of resolution of viremia; three cases of long-term immunologically silent HCV infection were documented. CONCLUSIONS: Minipool nucleic acid-amplification testing has helped prevent the transmission of approximately 5 HIV-1 infections and 56 HCV infections annually and has reduced the residual risk of transfusion-transmitted HIV-1 and HCV to approximately 1 in 2 million blood units.

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References

1996The Risk of Transfusion-Transmitted Viral Infections 2002Current prevalence and incidence of infectious disease markers and estimated window‐period risk in the American Red Cross blood donor population

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2005A new strategy for estimating risks of transfusion‐transmitted viral infections based on rates of detection of recently infected donors 2019Prevention of transfusion-transmitted infections 2010Prevalence, incidence, and residual risk of human immunodeficiency virus and hepatitis C virus infections among United States blood donors since the introduction of nucleic acid testing 2007Transfusion-transmitted infections 2010Transfusion‐associated infections: 50 years of relentless challenges and remarkable progress 2011Donor Testing and Risk: Current Prevalence, Incidence, and Residual Risk of Transfusion-Transmissible Agents in US Allogeneic Donations 2008Experience of German Red Cross blood donor services with nucleic acid testing: results of screening more than 30 million blood donations for human immunodeficiency virus‐1, hepatitis C virus, and hepatitis B virus 2007Current Risks of Transfusion-Transmitted Agents: A Review

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