Document Detail


Nucleic acid assay system for tier II laboratories and moderately complex clinics to detect HIV in low-resource settings.
MedLine Citation:
PMID:  20225946     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
There is a clear need for an instrument-free molecular diagnostic system for detecting human immunodeficiency virus type 1 (HIV-1) RNA or DNA that can be used in developing countries. Such a test could be used for early diagnosis of HIV-1 infection during infancy and could serve as a surrogate end point for vaccine trials. We developed the IsoAmp HIV-1 assay (BioHelix Corporation), which targets the HIV-1 gag gene with use of isothermal reverse-transcription helicase-dependent amplification chemistry. The IsoAmp HIV assay uses a disposable amplicon containment device with an embedded vertical-flow DNA detection strip to detect the presence of HIV-1 amplicons. The vertical-flow DNA detection strip has a control line to validate the performance of the device and a test line to detect the analyte. The analyte is detected by a sandwich immunoassay for reporter moieties on a capture probe and a detection probe. The control line consists of the detection probe reporter moiety conjugated to the vertical-flow DNA detection strip. The preliminary limit of detection of the IsoAmp HIV assay was evaluated by testing serial dilutions of HIV-1 armored RNA (Assuragen). We found that 21 (75%) of 28 assays yielded positive results when 50 copies of HIV-1 armored RNA were input into the IsoAmp HIV reaction.
Authors:
Wen Tang; Wing Huen A Chow; Ying Li; Huimin Kong; Yi-Wei Tang; Bertrand Lemieux
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Publication Detail:
Type:  Evaluation Studies; Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.    
Journal Detail:
Title:  The Journal of infectious diseases     Volume:  201 Suppl 1     ISSN:  1537-6613     ISO Abbreviation:  J. Infect. Dis.     Publication Date:  2010 Apr 
Date Detail:
Created Date:  2010-03-15     Completed Date:  2010-04-19     Revised Date:  2011-09-26    
Medline Journal Info:
Nlm Unique ID:  0413675     Medline TA:  J Infect Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  S46-51     Citation Subset:  AIM; IM    
Affiliation:
BioHelix Corporation, Beverly, Massachusetts, USA.
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MeSH Terms
Descriptor/Qualifier:
DNA, Viral / genetics,  isolation & purification
HIV / genetics,  isolation & purification*
HIV Infections / diagnosis*,  virology*
Humans
Immunoassay / methods
Molecular Diagnostic Techniques / methods*
Nucleic Acid Amplification Techniques / methods*
RNA, Viral / genetics,  isolation & purification
Sensitivity and Specificity
Grant Support
ID/Acronym/Agency:
1R43AI066487-01/AI/NIAID NIH HHS; 1R43AI77418-01/AI/NIAID NIH HHS; R43 AI077418-01/AI/NIAID NIH HHS; R44 AI077418-02/AI/NIAID NIH HHS; R44 AI077418-03/AI/NIAID NIH HHS; R44 AI077418-04/AI/NIAID NIH HHS
Chemical
Reg. No./Substance:
0/DNA, Viral; 0/RNA, Viral
Comments/Corrections

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