Transfusion-associated human immunodeficiency virus type 1 from screened antibody-negative blood donors

Cases of human immunodeficiency virus type 1 (HIV-1) infection acquired from transfusion of screened antibody-negative blood have been reported since 1986. Recent reports have proposed new combination antibody assays or the addition of HIV-1 p24 antigen testing to enhance the screening of blood donations further. Since antibody testing for HIV-1 began in 1985, 700,000 donor units have been screened at US Army blood donor centers. The US Army blood donor/recipient "lookback" program recently identified two cases of HIV-1 infection that resulted from a screened negative donation. Samples from the implicated unit, as well as from previous donations from the same donor, were available for testing to assess the performance of current screening methods. Sequential donation samples were assayed by five different Food and Drug Administration-approved HIV-1 screening enzyme-linked immunosorbent assays, a Food and Drug Administration-approved Western blot, a recombinant envelope-based enzyme-linked immunosorbent assay, a p24 antigen capture assay, a radioimmunoprecipitation assay, and a polymerase chain reaction. The HIV-1 p24 antigen and genomic RNA material were detected in a donation that was screened as negative by four of the five Food and Drug Administration-licensed screening enzyme-linked immunosorbent assays. Two recipients of transfusion products from this donation became infected with HIV-1. A sample from a prior donation from this donor was negative for HIV-1 by all assays. The status of blood donors who are in the early stages of HIV-1 infection may not be detected by current screening methods. While this is a rare phenomenon, it highlights the need for technologic developments in screening methods to narrow the time between infection and detection. In addition, it emphasizes the need for more effective education and counseling to enhance the utility of self=deferral.