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Fourth-generation HIV-screening assays are the most advanced HIV serological tests. These assays have the capability to detect HIV antibody and HIV-1 p24 antigen simultaneously and were developed to detect acute as well as latent infections using a time and cost-saving strategy.
Most fourth generation diagnostics, however, are laboratory based tests (e.g. ELISAs) and are not appropriate for point-of-care application or for use in challenging environments such as remote developing world settings. Alere has developed a rapid test, the Determine® HIV-1/2 Ag/Ab Combo, which enables simultaneous differential detection of HIV antibodies and p24 antigen enabling differentiation of acute infection from antibody only seropositives.
Evaluation of the Determine HIV-1/2 Ag/Ab Combo in-house and in 9 clinical sites in Africa, Asia, Europe and Latin America shows excellent performance with a clinical sensitivity of 100% (for patients at chronic stage of infection ) compared to current standards of HIV detection as well as an improved detection of HIV infection of 2-20 days earlier (average of 5 days) than 3rd generation assays and, a specificity of 99.61% and 99.21% for the Antigen line and for the Antibody line respectively.