New framework seeks to expedite early TB diagnosis and treatment around the world

A new framework is helping researchers and manufacturers more efficiently design and evaluate new diagnostic tests for people with early-stage tuberculosis (TB), potentially saving thousands of lives.

TB is the ninth leading cause of death worldwide and the leading cause from a single infectious agent, ranking above HIV and AIDS, according to the World Health Organization. However, only a minority of those infected with TB bacilli fall ill with TB, and it’s often after several months to years.

Predicting who will become ill enables individuals to take preventive treatment, remain healthy and decrease further transmission. Novel tests that detect those at high risk of becoming ill are therefore urgently needed, especially for resource-poor settings where TB is rampant. Research to develop such TB prediction tests is ongoing.

All marketed TB diagnostic tests must be endorsed by the World Health Organization before implementation and are evaluated based on a specific set of criteria. Until this framework was developed, manufacturers and researchers did not have clear guidance on how products were evaluated.

Led by Prof. Frank Cobelens, the framework outlines clear and scientifically sound research designs and methodologies to guide the design and testing of new TB prediction tests in order to achieve WHO endorsement.

“This is a new way of looking at diagnostics that we hope will stimulate the development of new TB tests,” said Prof. Cobelens, noting that funding for TB research and innovation is very limited.

“This framework, which I believe is the first of its kind in the world, allows funders and researchers to ensure the process is more cost-effective and efficient from start to finish and ultimately, ensure patients have access to adequate testing sooner.”

Read the full paper, ‘An evaluation framework for new tests that predict progression from tuberculosis infection to clinical disease’, here.

Read more about AIGHD’s research priorities and learn more about our TB-focused projects.