Phase 1 evaluation criteria
The degree to which the proposed solution indicates potential to accurately and reliably detect low blood lead levels at the point of care. The degree to which the proposed solution includes a clear and evidence-based explanation for the scientific principle(s) underlying the solution, as well as specific and well-supported quantitative targets for analytical performance.
The degree to which the proposed solution comprehensively identifies potential pre-analytical, analytical, and post-analytical sources of error and how the solution design mitigates the most significant error sources (e.g., contamination). The degree to which the proposed solution includes credible quantitative targets for accuracy and replicability, and actionable strategies to reduce overall error in future development.
The degree to which the proposed solution demonstrates a clear understanding of user needs, given identified point-of-care design target(s) and associated clinical workflows and environments. The degree to which the proposed solution includes user-centered rationale for design decisions to date, rationale for solution performance in the context of user needs (and considering overall challenge target performance metrics), and plans to engage clinical and patient stakeholders in future development.
The degree to which the proposed solution shows potential for broad adoption to increase rates of testing and equity of access to testing. The degree to which the proposed solution includes clear plans for addressing affordability, scalability, and other factors that would enable implementation across a wide range of geographic and socioeconomic target populations — particularly children who are currently underserved.
The degree to which the submission describes an ambitious but achievable development plan for Phase 2 of the challenge and beyond, including a clear plan for prototyping, iteration, testing/validation, and evaluation of the test; reasonable estimates of budget requirements and resourcing opportunities beyond the challenge; and consideration of potential risks to deliver on that plan.
The degree to which the team demonstrates relevant expertise, recognizes gaps, and proposes approaches to mitigate gaps to further develop the proposed solution.
Target performance metrics
Solutions should be usable by non-laboratory personnel without training, meeting the FDA criteria of waived tests as defined in 42 CFR § 493.15b.
Solutions should indicate consideration of manufacturing and per-test costs required for broad adoption.