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?

To establish fit for purpose performance specifications and enable assessment of proficiency

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

• No gold standard or Composite Reference Standard against which to compare test performance.
• Acceptable standard for whether or not an animal is infected.
• Establishment of proficiency panels.
• Better understanding of risk categories. Defined criteria – requirement for specificity and sensitivity, PPV, NPV etc.
• Well-documented interaction between prevalence and test performance; variation of a test’s sensitivity and specificity with disease prevalence

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

• Data on reproducibility/repeatability of immunological or molecular tests.
• Availability of well-characterised (anonymous) biobanks of biological materials i.e., serum, blood, tissue etc., including experimentally infected animals, controls, and field cases.
• Validation requirements from WOAH etc.
• Detection trials in animals experimentally infected with M. bovis.
• Detection trials in animals experimentally infected with related Mycobacteria.
• Inter-laboratory proficiency ring trials.
• Field trials in known reactor animals to confirm infection status.
• Large scale field trials.
• Conduct extensive field validation studies to evaluate the performance, feasibility, and usability of new diagnostic tests in diverse bTB epidemiological settings, considering factors such as sensitivity, specificity, cost-effectiveness, and ease of implementation.
• Develop robust data management systems that enable efficient collection, integration, and analysis of bTB diagnostic data.
• Utilize advanced analytics, artificial intelligence, and machine learning techniques to extract meaningful insights and support evidence-based decision-making.
• Developing and adhering to standardized protocols and guidelines to promote consistency and reliability in bTB
  diagnostics.
• Consider latent class analyses of test performance.
• Follow STARD and QUADAS-2 guidelines for reporting and designing diagnostic accuracy studies.

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

The development on novel tests of host immune responses and direct/indirect pathogen detection in infection.
The development of novel tests that are dependent on biomarkers other than those related to the immune response of
the host

Existing knowledge including successes and failures