Antibody detection by agglutination–PCR (ADAP) enables early diagnosis of HIV infection by oral fluid analysis

Oral fluid (OF) is a highly effective substrate for population-based HIV screening efforts, as it is noninfectious and significantly easier to collect than blood. However, anti-HIV antibodies are found at far lower concentrations in OF compared with blood, leading to poor sensitivity and a longer pe...

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Bibliographic Details
Published in:Proceedings of the National Academy of Sciences - PNAS 2018-02, Vol.115 (6), p.1250-1255
Main Authors: Tsai, Cheng-ting, Robinson, Peter V., de Jesus Cortez, Felipe, Elma, Maria L. B., Seftel, David, Pourmandi, Narges, Pandori, Mark W., Bertozzi, Carolyn R.
Format: Article
Language:English
Subjects:
Agglutination
Antibodies
Assaying
Biological Sciences
Blood
Diagnosis
DNA - chemistry
Early Diagnosis
HIV
HIV Antibodies - analysis
HIV Antibodies - genetics
HIV Core Protein p24 - genetics
HIV Envelope Protein gp120 - genetics
HIV Envelope Protein gp41 - genetics
HIV Infections - diagnosis
HIV Infections - prevention & control
Human immunodeficiency virus
Humans
Immunoassay
Immunoassays
Infections
Mass Screening - methods
Medical diagnosis
Medical treatment
Physical Sciences
Polymerase chain reaction
Polymerase Chain Reaction - methods
Saliva - virology
Screening
Sensitivity
Sensitivity analysis
Sensitivity and Specificity
Sensitivity enhancement
Substrates
Workflow
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Summary:Oral fluid (OF) is a highly effective substrate for population-based HIV screening efforts, as it is noninfectious and significantly easier to collect than blood. However, anti-HIV antibodies are found at far lower concentrations in OF compared with blood, leading to poor sensitivity and a longer period of time from infection to detection threshold. Thus, despite its inherent advantages in sample collection, OF is not widely used for population screening. Here we report the development of an HIV OF assay based on Antibody Detection by Agglutination–PCR (ADAP) technology. This assay is 1,000–10,000 times more analytically sensitive than clinical enzyme-linked immunoassays (EIAs), displaying both 100% clinical sensitivity and 100% specificity for detecting HIV antibodies within OF samples. We show that the enhanced analytical sensitivity enables this assay to correctly identify HIV-infected individuals otherwise missed by current OF assays. We envision that the attributes of this improved HIV OF assay can increase testing rates of at-risk individuals while enabling diagnosis and treatment at an earlier time point.
ISSN:0027-8424
1091-6490
DOI:10.1073/pnas.1711004115