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: