Roadmap for the development of diagnostic test for bTB

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

Evaluation of phage-based direct M. bovis detection.

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

• Culture time.
• Detection in biological samples including faeces.
• Improved culture media.
• Sample concentration.
• Performing phage typing requires specialized technical expertise and facilities.
• Time and labor Intensive.
• Interpretation and standardization.
• Limited discriminatory power.

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

• Objective evaluation of candidate methods on reference samples.
• Consider latent class analyses.
• Follow STARD and QUADAS-2 guidelines for reporting and designing diagnostic accuracy studies.
• Development of enrichment broth.

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

Existing knowledge including successes and failures