A framework for the assessment and implementation of diagnostics in outbreak situations

Area of Science:

• Public Health
• Infectious Disease Diagnostics
• Regulatory Science

Background:

• Outbreak situations necessitate rapid identification of infected individuals and tracking of infectious agents.
• Development, assessment, and implementation of in vitro diagnostics (IVDs) are typically time- and resource-intensive.
• Streamlined processes are crucial for timely IVD availability during public health emergencies.

Purpose of the Study:

• To present a practical pathway for the outbreak use of IVDs.
• To guide countries experiencing outbreaks in adopting necessary diagnostic tests.
• To facilitate the expedited development, regulatory evaluation, and implementation of outbreak-use IVDs.

Main Methods:

• The paper outlines a pathway encompassing outbreak recognition, product development, regulatory evaluation, implementation, and monitoring.
• It highlights the consideration of existing streamlined assessment programs by regulatory bodies like the US FDA and WHO.
• Emphasis is placed on identifying key responsible parties and fostering transparency and communication.

Main Results:

• Countries can adopt existing IVDs without extensive performance studies by leveraging streamlined assessment programs.
• The pathway provides a structured approach to managing IVDs during outbreak situations.
• Clear identification of responsible parties ensures accountability and efficient progression.

Conclusions:

• Streamlined pathways are essential for the rapid deployment of IVDs during outbreaks.
• Leveraging existing international assessment programs can significantly reduce time and resource burdens for countries.
• Effective collaboration and communication among stakeholders are critical for successful IVD implementation in outbreak settings.