From the bench to the field in low-cost diagnostics: two case studies

Area of Science:

• Global Health
• Biomedical Engineering
• Diagnostic Technology

Background:

• University research in point-of-care (POC) diagnostics for global health is increasing.
• Many POC diagnostic devices fail to transition from laboratory research to real-world application.
• Field evaluation of diagnostic technologies under realistic conditions presents significant challenges.

Purpose of the Study:

• To examine the complex processes involved in moving POC diagnostic technology from the laboratory to the field.
• To identify strategies and lessons learned from developing and evaluating POC diagnostics for global health.
• To provide insights for designing diagnostic tests for resource-limited environments.

Main Methods:

• Two case studies were used to illustrate the development and evaluation process.
• Case Study 1: Development of a paper-based device for liver function testing.
• Case Study 2: Development of a device for sickle cell disease identification using aqueous multiphase systems (AMPS).

Main Results:

• The development process involved forming partnerships, prototyping, study design, and evaluation.
• Lessons learned encompass technical and procedural aspects of POC diagnostic development.
• Successful strategies for field deployment were identified through practical application.

Conclusions:

• Moving POC diagnostics from the lab to the field is a complex, multi-step process.
• The case studies offer practical strategies for partnership, prototyping, and evaluation.
• The findings are valuable for developing diagnostics in resource-limited settings and global health.