Document Detail

Evaluation of the Determine™ Fourth Generation HIV Rapid Assay.
MedLine Citation:
PMID:  23391823     Owner:  NLM     Status:  Publisher    
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.
Marieke Brauer; Johanna C De Villiers; Simnikiwe H Mayaphi
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-2-4
Journal Detail:
Title:  Journal of virological methods     Volume:  -     ISSN:  1879-0984     ISO Abbreviation:  J. Virol. Methods     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-2-8     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8005839     Medline TA:  J Virol Methods     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2013. Published by Elsevier B.V.
Department of Medical Virology, University of Pretoria/National Health Laboratory Service Tshwane Academic Division, Pathology Building, 5 Bophelo Road, Pretoria, South Africa. Electronic address:
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