Roadmap for the development of diagnostic tests for FMD

What are we trying to achieve and why? What is the problem we are trying to solve?

New diagnostic methods have been developed but validation is lacking for some serotypes and in field conditions.

What are the scientific and technological challenges
(knowledge gaps needing to be addressed)?

• Serological differentiation among cross-reacting serotypes
• Evaluate and validate LFDs/Ag detection pen-side tests for surveillance, response, and recovery
• Obtain field validation data for isothermal tests
• Validate portable equipment before being used in emergency situations
• Evaluate sensitivity and specificity of diagnostic tests and surveillance systems at global, regional, and national scale

What approaches could/should be taken to address the research question?

• Validate field tests in different endemic areas during disease outbreaks
• Negotiate access to archived samples
• Methods must be tested in the field

What else needs to be done before we can solve this need?

• Host response
• PCR/ loop-mediated isothermal amplification (LAMP)
• Antigen capture
• Access to samples for performing validation tests

Existing knowledge including successes and failures

Molecular and genetic technologies, including sequencing, are developing at an increasing rate both in terms of capability and affordability. The development of RT-LAMP represents an important breakthrough allowing greater use and access to molecular diagnostics. It is now possible to determine virus serotype using PCR, although only for certain virus pools, continued progress is needed to cover the global spectrum of FMD viruses. Progress has also been made in the development of pen-side rapid diagnostics, some with the ability to determine serotype. However, further advances in pen-side serotype or strain determination would benefit both FMD-free countries and endemic countries with limited access to well-resourced laboratories. There are validations for a few serotypes. Recently developed methods are not already tested in the field.