title: Evaluation of the Determine™ fourth generation HIV rapid assay.
abstract: Assays that detect p24 antigen reduce the diagnostic window period of HIV testing. Most point-of-care HIV assays have poor sensitivity to diagnose acute HIV infection as they only detect antibodies against HIV-1 and HIV-2 (HIV-1/2). This was a cross-sectional laboratory-based study that evaluated the performance of the Determine™ HIV-1/2 Ag/Ab Combo fourth generation rapid strip - currently the only rapid assay that detects both HIV-1/2 antibodies and p24 antigen. A total of 79 serum specimens (29 positive for HIV antibodies only, 14 positive for HIV antibodies and p24 antigen, 20 HIV-negative, and 16 positive for p24 antigen only) were used for the evaluation. Results were compared with those from validated fourth generation HIV ELISAs. The Determine™ Combo rapid strips had a sensitivity of 90.7% and a specificity of 100% for the detection of HIV-1/2 antibodies. Its sensitivity for the detection of p24 antigen was only 10% (3 out of 30 p24 antigen positive specimens). This implies that most acute HIV infections will be missed with this assay. The need for a point-of-care assay which can detect acute HIV infection reliably still remains, particularly for use in a high prevalence setting such as South Africa.
authors: Department of Medical Virology, University of Pretoria/National Health Laboratory Service Tshwane Academic Division, Pathology Building, 5 Bophelo Road, Pretoria, South Africa. marieke.brauer@up.ac.za
authors: Marieke
authors: M
authors: Brauer
authors: Johanna C
authors: JC
authors: De Villiers
authors: Simnikiwe H
authors: SH
authors: Mayaphi
mesh_terms: D003430:Cross-Sectional Studies; D015483:HIV Antibodies / Q000032:analysis / Q000097:blood* / Q000276:immunology; D015488:HIV Antigens / Q000097:blood / Q000276:immunology; D016655:HIV Core Protein p24 / Q000032:analysis / Q000097:blood* / Q000276:immunology; D015658:HIV Infections / Q000175:diagnosis* / Q000276:immunology; D006679:HIV Seropositivity; D015497:HIV-1 / Q000276:immunology*; D015498:HIV-2 / Q000276:immunology*; D006801:Humans
chemical_list: D015483:HIV Antibodies; D015488:HIV Antigens; D016655:HIV Core Protein p24