Development of Rapid Diagnostic Assays
Mondial Diagnostics combines specialized expertise and operational excellence in the development of rapid point-of-care diagnostic tests for poverty-related diseases.
Our team handles:
- Initial design, product development plan, and protocols
- Development of key components, such as antigens and antibodies
- Feasibility testing
- Development and optimization of a prototype assay
- Laboratory validation and clinical validation on retrospective samples
- Field studies for full-scale, prospective validation
- Product documentation
- Standard Operating Procedures for manufacturing and quality assurance
- Transfer to manufacturing
Assay Development Services
Mondial Diagnostics' expertise is also available for co-development projects and for assay development, optimization, and/or validation on a fee-for-service basis.
Other partners in our elaborate global network can be included in a development project, for instance to:
- integrate a novel technology platform
- use a different detection label (with or without a reader)
- integrate an assay with digital/mobile health connectivity