Diagnosis and medical management of HIV-infected individuals is significantly enhanced if one can simultaneously define the subset of the most common co-infections for which patients are at risk. Unfortunately, running such a series of parallel diagnostic tests is cost prohibitive, particularly in low-resource settings. Precision Photonics Corporation proposes to continue development of a low-cost, point-of-care, multiplexed fluorescence immunoassay system for the diagnosis of HIV and common co-infections from a single sample. The technology uses a proprietary laser illumination method combined with low- cost consumer electronics (e.g., DVD player lasers) and optics (consumer and cell phone cameras).
The specific aims of the proposed project are to: (1) Transfer the reference design fluorescence reader and cartridge system completed during Phase II into an investigational device, positioned for an investigational device exemption (IDE) application to the FDA, including a fluorescent reader, cartridge, and system software. (2) Expand the multiplexed co-infection assay panel to include M. tuberculosis serology based on a panel of new diagnostic antigens and direct detection of hepatitis B surface antigen and Cryptococcus antigen.
Aim 2 will also establish stabilization protocols, reagent packaging, and shelf life dataset, as well as quality assurance/quality control procedures. (3) Place instruments at collaborator sites and develop datasets based on three collections of clinical samples, including a cohort of archived samples collected through UCSD clinics;samples collected from international sites through collaboration with the NIAID AIDS Clinical Trials Group (ACTG);and clinical samples collected and tested in Brazil. The outcome of this program will be a low cost, IDE-stage instrument with working diagnostic panel assays and a validated dataset to be bundled as part of an FDA submission.
The research and development performed in this project, if successful, will enable very low cost, easy to use tests at the point-of-care to help in the assessment of disease status of AIDS patients, particularly in resource limited settings. The simplicity and low cost of the technology will facilitate the use of antiretroviral therapy, greatly prolonging the lives of those infected with HIV and reducing the burden of disease in populations where HIV is endemic.
