Novel devices must demonstrate feasibility of MTB cell inactivation (by standard biosafety analysis protocols) and lysis (as compared to mechanical lysis via bead beating or sonication) without the need for a reusable instrument. (New Manual Quantitative Polymerase Chain Reaction Assay Validated on Tongue Swabs Collected and Processed in Uganda Shows Sensitivity That Rivals Sputum-based Molecular Tuberculosis Diagnostics).
- The resulting lysate must be stable for up to 72 hours at temperatures up to 40°C and humidity up to 70% without the need for cold chain.
- Ideally, no additional instruments should be required to complete the steps. However, if any are necessary, they must be compact, easily transportable, battery-powered, and cost-effective (under $50 USD).
- The solution must be simple and safe enough to be performed at home by a lay user or by a low-level health care worker.
- Sample Clean up and Analyte Concentration
- Pre analytical solutions to improve analyte quality for improved assay performance including but not limited to sample clean up, analyte concentration, and interference removal.
- The solution must demonstrate equivalence with laboratory sample clean up methods and analyte concentration kits.
- Evaluation Criteria:
- Feasibility and innovation in meeting collection, processing, and/or lysis requirements.
- Cost-effectiveness and scalability.
- Analytical performance and validation data as per published guidelines.
- Alignment with decentralized or PoC needs as per published guidelines.
- Product shelf life at ambient temperature, and transportation stability in target LMIC countries as suggested by Global Fund Priority Country List.
- Eligibility Criteria
- This initiative is open to nonprofit organizations, for-profit companies, international organizations, government agencies, and academic institutions. We particularly encourage applications involving projects led by women or from women-led organizations and applications from institutions based in low- and middle-income countries.
- Funding Level
- We will consider proposals for awards of $100,000 to $250,000 USD for each project, with a grant term of up to 2 years. Application budgets should be commensurate with the scope of work proposed. Indirect costs will be considered and should be included in the budget for the up to the grant amount awarded (subject to the Gates Foundation’s indirect cost policy). For more information and to apply on or before March 25, go to: https://submit.gatesfoundation.org/prog/enhancing_hiv_and_tb_diagnosis_adjunct_technologies_for_sample_collection_and_processing/
