Brauer, MariekeDe Villiers, J.C. (Johanna Corrie)Mayaphi, Simnikiwe Horatious2013-10-112013-10-112013-04Brauer, M, De Villiers, JC & Mayaphi, SH 2013, 'Evaluation of the Determine™ fourth generation HIV rapid assay', Journal of Virological Methods, vol. 189, no. 1, pp. 180-183.0166-0934 (print)1879-0984 (online)10.1016/j.jviromet.2013.01.017http://hdl.handle.net/2263/32008Assays 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 DetermineTM 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 DetermineTM 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.en© 2013 Elsevier B.V. All rights reserved. Notice : this is the author’s version of a work that was accepted for publication in Journal of Virological Methods. Changes resulting from the publishing process, such as peer review, editing, corrections, structural formatting, and other quality control mechanisms may not be reflected in this document. Changes may have been made to this work since it was submitted for publication. A definitive version was subsequently published in Journal of Virological Methods, vol. 189, no.1, 2013. doi.: 10.1016/j.jviromet.2013.01.017HIVRapidAcuteFourth generation testSeroconversionHIV infections -- Diagnosis -- South AfricaPostprint Article