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We compared an automated microparticle double-antigen sandwich enzyme immunoassay (EIA) for the IMx test system recently developed by Abbott with two established assays (the automated indirect Vidas IgG EIA and the double-antigen sandwich EIA from Murex/Wellcome) devised for the detection of human immunodeficiency virus type 1 (HIV-1) and HIV-2 antibodies. A total of 1,078 consecutive serum samples were tested prospectively with the three assays. In addition, we used retrospectively selected panels of serum samples with discrepant results in two different screening tests and with indeterminate or positive Western immunoblot (WB) results, as well as five commercially available HIV-1 seroconversion panels. The new assay showed excellent discriminatory characteristics for the separation of samples from HIV-1-positive and HIV-1-negative persons according to Centers for Disease Control and Prevention WB criteria. The sensitivities were 98.1, 92.9, and 96.1% for the new test and the two other assays, respectively, and the specificities were 99.7, 97.9, and 98.1%, respectively. With the seroconversion panels this new test was positive several days earlier than the two other assays; i.e., seroconversion was evident at the peak of p24 antigenemia and often several weeks before WB became positive by the most stringent criteria.

Detection of human immunodeficiency virus (HIV) type 1 antibodies by new automated microparticle enzyme immunoassay for HIV types 1 and 2