Rapid HIV Point-of-Care Diagnostic Device for Resource-Limited Settings
This BAA solicitation for Rapid HIV point-of-care Diagnostic Device for resource-limited settings (hereinafter referred to as rapid virus test) seeks to fund a consortium of scientists with a breadth of complementary skills and expertise in clinical HIV research, the associated molecular technology, diagnostics, validation testing, GMP manufacturing and project management to develop a simple to use, rapid, point-of-care (POC) HIV diagnostic devices with candidate vaccine constructs and developed vaccine-induced antibodies in the absence of true HIV-1 infections and HIVinfected infants. The diagnostic technology must demonstrate feasibility for use in resource-limited settings and in POC clinics without the use of supporting laboratory equipment such as centrifuges, vortexes or pipettes. In addition, if proposed testing requires processing of patient samples for downstream applications, the processing must be selfcontained and require limited sample manipulation and safe containment of potentially infectious material. The output should be in a visual format, without ambiguity, and include a full process negative and internal positive control. It is anticipated that 1 to 2 cost reimbursement, completion type contracts will be awarded on August 3, 2009 for a period of up to five years for the base period and options in years 3 and 4 for additional services; studies for a similar device to make limited treatment decisions based on viral load.
