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

Detection of HIV-1 and HCV Infections among Antibody-Negative Blood Donors by Nucleic... BackgroundTesting 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.MethodsWe 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.ResultsAmong 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.ConclusionsMinipool 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. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png The New England Journal of Medicine The New England Journal of Medicine

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

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References (34)

Publisher
The New England Journal of Medicine
Copyright
Copyright © 2004 Massachusetts Medical Society. All rights reserved.
ISSN
0028-4793
eISSN
1533-4406
DOI
10.1056/NEJMoa040085
pmid
15317889
Publisher site
See Article on Publisher Site

Abstract

BackgroundTesting 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.MethodsWe 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.ResultsAmong 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.ConclusionsMinipool 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.

Journal

The New England Journal of Medicine – The New England Journal of Medicine

Published: Aug 19, 2004

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