Cell analysis & immunoassay device for distributed HIV diagnosis and monitoring

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DESCRIPTION (provided by applicant): The goal of this research is to develop a new approach to bring diagnosis and monitoring tests for HIV to the primary care level (primary care provider office, small healthcare clinics and labs, and community health center labs) by introducing a multi-functional cell analysis and immunoassay platform that is portable, low cost and easy to use. It will allow patients to be tested for routine blood tests (complete blood count or CBC), an essential test in primary care, and also permit tests for detection of HIV infection (HIV-antibody and antigen tests) and CD4 counts on the same system. In the future the proposed system will allow the introduction of bead-based nucleic acid testing for HIV. This platform will improve HIV treatment outcomes by diagnosing HIV early, enhancing patient readiness for initiation of antiretroviral medications, improving and sustaining patient adherence to antiretroviral medications, and improving patient retention in medical care. Additionally, as immune suppressed HIV patients are more susceptible to opportunistic infections and are often prone to also suffer from anemia and other hematological issues, by enabling the diagnosis of such conditions early at the primary care level, this platform will help the physicians better manage the overall health of these patients. This novel platform will be accomplished by combining technologies for fluorescence based flow cytometry and all-optical automated hematology analysis in a synergistic way, leveraging patent pending assay protocols and unique hardware/software designs and components. By rendering diagnostic results more quickly, the proposed system has the potential to increase the level of awareness of HIV infection status in patients, permitting improved education and behavior modification for infected individuals. Rapid return of results in distributed care settings also has the potential to reduce the loss to follow-p that is often associated with long turnaround times for test results, particularly in resource-limited settings. Similarly, performing CD4 monitoring at or closer to the point of care has the potential to improve the quality of care and reduce morbidity significantly, enabling heath care providers to adjust treatment more rapidly and appropriately, in order to assure improved treatment outcomes. Together, these will contribute significantly to reduce the impact of the global HIV epidemic by reducing the spread of infection through awareness, and by improving the quality of treatment, thus mitigating the societal impact associated with HIV morbidity and mortality due to uncontrolled HIV disease.