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Mobile Health Point-of-Care Diagnostics

Description:

Fast-Track proposals will be accepted Number of anticipated awards: 1-2 Budget (total costs): Phase I: up to $300,000 for up to 1 year; Phase II: up to $1,500,000 for up to 3 years

PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.

Background:

The capabilities inherent in smartphones represent a largely untapped opportunity to improve point-of-care (POC) diagnostics for infectious diseases in low resource settings (LRS), where laboratory equipment is scarce and infrastructure is often unreliable. Smartphone features that could be adapted to enhance POC diagnostics include fast computing power, internet connectivity, geo-positioning, a high-quality camera, and long-lasting power/batteries. Smartphones have the potential to increase POC diagnostic sensitivity and specificity through machine-interpreted results; reduce operator error by ensuring accurate collection of data and relevant metadata; and improve analysis and stewardship of results through remote analysis and data storage. Further development of novel technologies, computational tools, and algorithms is needed to transform smartphones into platforms capable of improving POC diagnostic performance, interpretation of results, and data transmission.

Project Goals:

The goal of this solicitation is to develop both i) a low cost, rapid, easy-to-use, smartphone-compatible, infectious disease POC diagnostic for use in LRS; and ii) computational tools and algorithms necessary to effectively link the diagnostic test to the smartphone and achieve enhanced performance. The final products should be independent of smartphone manufacturer and operating system, and a physical connection between the test and the smartphone is not required. Algorithms should at a minimum capture all information needed to use, read, and interpret the test (for example in a 2D barcode), as well as provide verification that the test was run correctly. Ideally, the diagnostic test time from sample to answer should be one hour or less including sample processing. Stability of assay reagents at room temperature is preferred.

The development of a smartphone-compatible POC diagnostic and all associated technologies, computational tools and algorithms that address the following research areas are of particular interest:

• Improved sensitivity and reduced time to diagnosis for tuberculosis

• Improved sensitivity for malaria diagnosis

• Ability to accurately distinguish between influenza and other respiratory pathogens

• Ability to accurately distinguish between bacterial and viral pneumonia

• Detection of onchocerciasis (river blindness) adult worms

Phase I activities may include:

Development of a smartphone-compatible, low cost, field-portable, rapid POC diagnostic

• Development of a functional software prototype to enhance the performance of the POC diagnostic

• Integration of the diagnostic assay and the smartphone without requiring high cost adapters, and independent of the smartphone manufacturer

• Determination of sensitivity, specificity and other performance characteristics (e.g. time to result, limit of detection, test stability) of the diagnostic

• Confirmation that accuracy is sufficient to allow clinically relevant results

• Demonstration of software capabilities to ensure accurate data collection, identify failure modes, interpret and share results in a secure environment

• Performance of initial testing on laboratory isolates

Phase II activities may include:

Further optimization of the smartphone-linked assay platform technology and validation of assay reproducibility

• Testing of de-identified clinical samples from diverse cohorts with varying levels of infection

• Evaluation, revision, and enhancement of the software prototype

• Performance of software beta testing with relevant end users

This SBIR Topic will not support:

The development of a prototype POC diagnostic alone without the associated technologies, computational tools and algorithms required to integrate with a smartphone

The design and conduct of clinical trials (see Appendix H.1 for the NIH definition of a clinical trial).

For clinical trial support, please refer to the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement program announcement or the NIAID Investigator-Initiated Clinical Trial Resources webpage.

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