A multidisciplinary group of judges will recommend winners after evaluating submissions based on the following equally weighted criteria. Entrants should also consider and address target performance metrics in their submissions.
Phase 1 submissions will be evaluated by judges against the six official evaluation criteria described below.

Phase 1 evaluation criteria

Analytical performance

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.

Error mitigation

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.

User-centered design

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.

Accessibility

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.

Development plan

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.

Team

The degree to which the team demonstrates relevant expertise, recognizes gaps, and proposes approaches to mitigate gaps to further develop the proposed solution.

Phase 2

The Lead Detect Prize expects to evaluate Phase 2 submissions using the same six headline Phase 1 evaluation criteria, with increased fidelity requirements. Phase 2 criteria may change based on the results of Phase 1. The challenge will publish updated Phase 2 criteria prior to the launch of Phase 2.

Target performance metrics

In Phase 1, the target performance metrics serve as guidance for an eventual FDA-cleared product. In Phase 2 and beyond, the challenge may adjust or specify target performance metrics as quantitative performance requirements.

Operating parameters

Limit of detection

Solutions should seek to reliably detect blood lead levels at or below 1.5 μg/dL.

Measurement precision

Solutions should demonstrate the potential to test blood lead concentrations spanning the reportable range that includes important decision points of 3.5 μg/dL, 20 μg/dL, and 45 μg/dL. Precision should be adequate to support the claimed measurement range.

Measurement accuracy

Solutions should indicate the ability to achieve accuracy within ±2 μg/dL or ±10%, whichever is greater, of the true blood lead concentration for 80% of samples analyzed across the reportable range.

Analysis time

Solutions should indicate the feasibility of the machine in providing results in about five minutes.

Result reporting

Solutions should be capable of electronically displaying quantitative results and directly transferring this data to electronic health information systems in formats such as HL7.

Sample collection

Solutions should minimize the required sample volume, with a target of ≤150 µL, and must use a capillary blood draw that includes steps to minimize contamination.

Development parameters

Ease of use

Solutions should be usable by non-laboratory personnel without training, meeting the FDA criteria of waived tests as defined in 42 CFR § 493.15b.

Cost

Solutions should indicate consideration of manufacturing and per-test costs required for broad adoption.

Submissions for Phase 1 are now closed.