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 characterise the humoral immune response during infection – can the humoral response be reliably used to identify infection status?

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

• Establishing the earliest points that specific humoral responses can be detected.
• Trade-off between antigen sensitivity and specificity.
• The interaction between the humoral response and earlier tuberculin skin testing (anamnestic response).
• Immunoreactivity indexes exposure; cannot currently distinguish from true, productive infection.
• Distinguishing immune responses induced by vaccination from those triggered by natural infection (DIVA).
• Identifying specific antigens or epitopes that are recognized by antibodies during bTB infection.

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

Investigating the timing, magnitude, and persistence of antibody production, as well as the correlation between antibody levels and disease progression or treatment response.
Longitudinal studies monitoring the antibody response (including antibody isotype and subclasses) during experimental infection.
Overcoming challenges associated with cross-reactivity, variations in antibody responses among individuals, and
differences in test performance across diverse populations.
Control for host genetic background.

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

Improved understanding of host-pathogen interactions.

Existing knowledge including successes and failures