Prevalence of human immunodeficiency virus type 1 p24 antigen in U.S. blood donors - An assessment of the efficacy of testing in donor screening

Harvey J. Alter, Jay S. Epstein, Sally G. Swenson, Mark J. VanRaden, John W. Ward, Richard A. Kaslow, Jay E. Menitove, Harvey G. Klein, S. Gerald Sandler, Merlin H. Sayers, Indira K. Hewlett, Amoz I. Chernoff, Mark Popovsky, Hilda McDonald, Jay Herman, William Sherwood, Jan Forey, Kate Rothko, Paul Ness, Sandy EllisorGerald Shulman, Alfred Grindon, Steven Kleinman, Bruce Lenes, Peter Tomasulo, Ron Gilcher, Linda Chandler, Linda Belcher, Pablo Fortes, David Fortenberry, Jay Menitove, Ernest Simon, Mike Busch, Herbert Perkins, Robert Randell, Paul Holland, German Leparc, Paul Schmidt, Mark Rayfield, Lynda Doll, Lyle Peterson

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Abstract

Background. We performed a multicenter study in 1989 to determine whether screening whole-blood donors for human immunodeficiency virus type 1 (HIV-1) p24 antigen would improve transfusion safety by identifying carriers of the virus who are seronegative for HIV-1 antibody. Methods. More than 500,000 donations were tested at 13 U.S. blood centers with test kits from two manufacturers. Units found repeatedly reactive were retested in a central laboratory; if the results were positive, they were confirmed by a neutralization assay. A subgroup of units was also tested for HIV-1 by the polymerase chain reaction. Selected donors confirmed or not confirmed as having p24 antigen were contacted for follow-up interviews to identify risk factors and undergo retesting for HIV-1 markers. Results. Positive tests for p24 antigen were confirmed by neutralization in five donors (0.001 percent of all donations tested), all of whom were also positive for HIV-1 antibody and HIV-1 by polymerase chain reaction. Three of the antigen-positive donors had other markers of infectious disease that would have resulted in the exclusion of their blood; two had risk factors for HIV-1 that should have led to self-exclusion. Of 220 blood units with repeatedly reactive p24 antigen whose presence could not be confirmed by neutralization (0.04 percent of the donations studied), none were positive for HIV-1 antibody, HIV-1 by polymerase chain reaction (120 units tested), or virus culture (76 units tested) - attesting to the specificity of confirmatory neutralization. Conclusions. The finding that no donation studied was positive for p24 antigen and negative for HIV-1 antibody suggests that screening donors for p24 antigen with tests of the current level of sensitivity would not add substantially to the safety of the U.S. blood supply.

Original languageEnglish (US)
Pages (from-to)1312-1317
Number of pages6
JournalNew England Journal of Medicine
Volume323
Issue number19
StatePublished - Nov 8 1990
Externally publishedYes

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ASJC Scopus subject areas

  • Medicine(all)

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Alter, H. J., Epstein, J. S., Swenson, S. G., VanRaden, M. J., Ward, J. W., Kaslow, R. A., Menitove, J. E., Klein, H. G., Sandler, S. G., Sayers, M. H., Hewlett, I. K., Chernoff, A. I., Popovsky, M., McDonald, H., Herman, J., Sherwood, W., Forey, J., Rothko, K., Ness, P., ... Peterson, L. (1990). Prevalence of human immunodeficiency virus type 1 p24 antigen in U.S. blood donors - An assessment of the efficacy of testing in donor screening. New England Journal of Medicine, 323(19), 1312-1317.