Detection of HIV-1 and HCV Infections among Antibody-Negative Blood Donors by Nucleic AcidAmplification 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
Background Testing of blood donors for human immunodeficiencyvirus type 1 (HIV-1) and hepatitis C virus (HCV) RNA by meansof nucleic acid amplification was introduced in the United Statesas an investigational screening test in mid-1999 to identifydonations made during the window period before seroconversion.
Methods We analyzed all antibody-nonreactive donations thatwere confirmed to be positive for HIV-1 and HCV RNA on nucleicacidamplification testing of "minipools" (pools of 16to 24 donations) by the main blood-collection programs in theUnited States during the first three years of nucleic acid screening.
Results Among 37,164,054 units screened, 12 were confirmed tobe 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 tobe positive for HCV RNA, or 1 in 230,000 donations (or 1 in270,000 on the basis of 139 donations confirmed to be positivefor HCV RNA with the use of a more sensitive HCV-antibody test).The respective rates of positive HCV and HIV-1 nucleic acidamplificationtests were 3.3 and 4.1 times as high among first-time donorsas among donors who gave blood repeatedly. Follow-up studiesof 67 HCV RNApositive donors demonstrated that seroconversionoccurred a median of 35 days after the index donation, followedby a low rate of resolution of viremia; three cases of long-termimmunologically silent HCV infection were documented.
Conclusions Minipool nucleic acidamplification testinghas helped prevent the transmission of approximately 5 HIV-1infections and 56 HCV infections annually and has reduced theresidual risk of transfusion-transmitted HIV-1 and HCV to approximately1 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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