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Original Article
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Volume 351:760-768 August 19, 2004 Number 8
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Detection of HIV-1 and HCV Infections among Antibody-Negative Blood Donors by Nucleic Acid–Amplification Testing
Susan L. Stramer, Ph.D., Simone A. Glynn, M.D., M.P.H., Steven H. Kleinman, M.D., D. Michael Strong, Ph.D., Sally Caglioti, M.T. (A.S.C.P.), S.B.B., David J. Wright, Ph.D., Roger Y. Dodd, Ph.D., Michael P. Busch, M.D., Ph.D., for the National Heart, Lung, and Blood Institute Nucleic Acid Test Study Group

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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.


Source Information

From the American Red Cross, Gaithersburg, Md. (S.L.S.), and Rockville, Md. (R.Y.D.); Westat, Rockville, Md. (S.A.G., S.H.K., D.J.W.); the University of British Columbia, Victoria, B.C., Canada (S.H.K.); Puget Sound Blood Center, Seattle (D.M.S.); Blood Systems Laboratory, Tempe, Ariz. (S.C., M.P.B.); Blood Systems Research Institute, Blood Centers of the Pacific, San Francisco (M.P.B.); and the University of California, San Francisco (M.P.B.).

Address reprint requests to Dr. Stramer at the American Red Cross National Testing and Reference Laboratories, 9315 Gaither Rd., Gaithersburg, MD 20877, or at stramers{at}usa.redcross.org.

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Related Letters:

HIV-1 and HCV Infections among Antibody-Negative Blood Donors
Begovac J., Mihaljevic I., Perrin L., Laperche S., Pillonel J., Herve P., Prince A. M., Kainer M. A., Jarvis W. R., Stramer S. L., Dodd R. Y., Busch M. P., Goodman J. L.
Extract | Full Text | PDF  
N Engl J Med 2004; 351:2232-2235, Nov 18, 2004. Correspondence

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