Document Detail

p24 antigen rapid test for diagnosis of acute pediatric HIV infection.
MedLine Citation:
PMID:  20811289     Owner:  NLM     Status:  MEDLINE    
Currently, the majority of HIV-infected infants are found within limited-resource settings, where inadequate screening for HIV due to the lack of access to simple and affordable point-of-care tests impedes implementation of antiretroviral therapy. Here we report development of a low-cost dipstick p24 antigen assay using a visual readout format that can facilitate the diagnosis of HIV for infants in resource-poor conditions. A heat shock methodology was developed to optimize disruption of immune complexes present in the plasma of infected infants. The analytical sensitivity of the assay using recombinant p24 antigen is 50 pg/mL (2 pM) with whole virus detection as low as 42.5k RNA copies per milliliter plasma. In a blinded study comprising 51 archived infant samples from the Women and Infants Transmission Study, our assay demonstrated an overall sensitivity and specificity of 90% and 100%, respectively. In field evaluations of 389 fresh samples from South African infants, a sensitivity of 95% and specificity of 99% was achieved. The assay is simple to perform, requires minimal plasma volume (25 μL), and yields a result in less than 40 minutes making it ideal for implementation in resource-limited settings.
Zaheer A Parpia; Robert Elghanian; Arman Nabatiyan; Diana R Hardie; David M Kelso
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Publication Detail:
Type:  Evaluation Studies; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of acquired immune deficiency syndromes (1999)     Volume:  55     ISSN:  1944-7884     ISO Abbreviation:  J. Acquir. Immune Defic. Syndr.     Publication Date:  2010 Dec 
Date Detail:
Created Date:  2010-11-05     Completed Date:  2011-01-04     Revised Date:  2011-09-06    
Medline Journal Info:
Nlm Unique ID:  100892005     Medline TA:  J Acquir Immune Defic Syndr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  413-9     Citation Subset:  IM; X    
Department of Biomedical Engineering, Center for Innovation in Global Health Technologies, Northwestern University, Evanston, IL, USA.
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MeSH Terms
Africa South of the Sahara
Antibodies, Monoclonal / immunology
HIV / isolation & purification*
HIV Antibodies / immunology
HIV Core Protein p24 / blood*,  immunology
HIV Infections / diagnosis*
Infant, Newborn
Reagent Strips
Recombinant Proteins / blood,  immunology
Sensitivity and Specificity
United States
Reg. No./Substance:
0/Antibodies, Monoclonal; 0/HIV Antibodies; 0/HIV Core Protein p24; 0/Reagent Strips; 0/Recombinant Proteins

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