Gaps and Solutions

TB diagnostic innovators and other stakeholders identified some of the frequently encountered gaps and challenges along the pathway, along with potential solutions to address them. This is a living resource and we welcome your feedback on these and other issues and/or solutions along the pathway. 

Access to Clinical Specimens During Development
Access to Clinical Specimens During Development

Critical for assay developers to validate their assay. The critical steps along the pathway for assay development when specimen banks might be required include: prototype and optimization studies, and validation and verification studies.


FIND Specimen Bank


BCCM/ITM strain collection

Clinician Sensitization
Clinician Sensitization

Engagement of medical staff and TB doctors is critical for sustained uptake of new TB diagnostics.


Clinician-focused training – clinical utility of new TB tool


Partner with GLI and NTPs to jointly develop training

Community Engagement
Community Engagement

Gather voice of community via focus groups or forums e.g. STBP TB Champion Advocacy Training


Conduct participatory action research (PAR) at every feasible stage – local and global advocacy groups - TB Proof, TAG


Involve TB champions from within community - include in capacity building workshops


Utilize universally designed language in multiple languages


Key organizations: Global advocacy partners e.g.  TAG, and local advocacy partners e.g. TB Proof

Country Evaluations
Country Evaluations

Engage country reference labs as partners early in development and evaluation to eventually help support country algorithm and policy development

Local NGOs funded via TB-REACH or similar projects provide an alternate path for operational research, e.g. Jointed Hands (Zimbabwe)PAS (Moldova)IRD (Pakistan)