Failure of Routine HIV-1 Tests in a Case Involving Transmission With Preseroconversion Blood Components During the Infectious Window Period

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Abstract
In the United States, donated blood and plasma is tested for antibodies to human immunodeficiency virus types 1 (HIV-1) and 2 (HIV-2) by screening with an enzyme immunoassay (EIA), as well as an HIV-1 p24 antigen EIA.1 Despite a dramatic reduction in risk due to the improved sensitivity of these tests, it is estimated that from 1 in 450,000 to 1 in 660,000 US blood donations may transmit HIV,2,3 with nearly all cases of transfusion-associated HIV infection being caused by donations made during the infectious window period, prior to seroconversion. Contemporary HIV EIAs have an average infectious window period of 25 days.4 The p24 antigen becomes detectable 2 to 3 weeks after HIV infection during the period of high-level viremia associated with the initial burst of virus replication5,6 and, on average, can be detected about 6 days before antibody tests become positive.7 Using a test based on nucleic acid amplification (NAT), it is possible to detect HIV RNA 5 to 10 days prior to p24 antigen detection, which has proven useful in confirming HIV diagnostic serology.8,9 Currently, HIV NAT testing is being evaluated in clinical trials regarding its use in routine screening of blood and plasma donations. Ninety-nine percent of plasma collected in the United States is tested with a NAT assay for HIV and hepatitis C virus (HCV).10