Department of Medical Virology, University of Pretoria, National Health Laboratory Service Tshwane Academic Division, Pathology Building, 5 Bophelo Road, Pretoria, South Africa
Brauer, M., Department of Medical Virology, University of Pretoria, National Health Laboratory Service Tshwane Academic Division, Pathology Building, 5 Bophelo Road, Pretoria, South Africa; De Villiers, J.C., Department of Medical Virology, University of Pretoria, National Health Laboratory Service Tshwane Academic Division, Pathology Building, 5 Bophelo Road, Pretoria, South Africa; Mayaphi, S.H., Department of Medical Virology, University of Pretoria, National Health Laboratory Service Tshwane Academic Division, Pathology Building, 5 Bophelo Road, Pretoria, South Africa
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. © 2013 Elsevier B.V.
antigen p24; Human immunodeficiency virus 1 antibody; Human immunodeficiency virus 2antibody; Human immunodeficiency virus antibody; unclassified drug; antigen detection; article; controlled study; diagnostic accuracy; diagnostic test accuracy study; enzyme linked immunosorbent assay; HIV test; human; human cell; Human immunodeficiency virus infection; intermethod comparison; point of care testing; priority journal; sensitivity and specificity; validity; virus detection; Cross-Sectional Studies; HIV Antibodies; HIV Antigens; HIV Core Protein p24; HIV Infections; HIV Seropositivity; HIV-1; HIV-2; Humans; Human immunodeficiency virus 1; Human immunodeficiency virus 2