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

Significance There is a substantial public health interest in identifying HIV-infected individuals through population-based screening. Oral fluid (OF) is easier to collect than blood and therefore ideal for such screening efforts. Unfortunately, OF has a very low concentration of anti-HIV antibodies (markers of HIV infection), which current assays cannot detect during the early stage of this disease. Here we report an assay for anti-HIV antibodies in OF that is up to 10,000 times more sensitive than current alternatives. This assay, called Antibody Detection by Agglutination–PCR (ADAP), could be broadly deployed to screen at-risk populations using OF in many settings, including those where cold chain shipping is not available (low-resource settings) and where needles are inconvenient (pediatrics) or unsafe (prisons). 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.