According to the World Health Organization’s End TB strategy, approximately three million TB cases go undetected each year. This is often due to inadequate tests that are either not sensitive enough or require sophisticated laboratory infrastructure that is not always available, especially not in rural settings.

The high burden of undiagnosed TB fuels on-going transmission and poor treatment outcomes. Better tests are needed at point-of-care, where triage in low-resource settings is essential to prioritize those with the highest risk of TB disease to higher levels of care.

TriageTB’s goal is to field-validate a rapid point-of-care triage test for active TB that can be conducted in a laboratory-free manner. The project is included in a large-scale international research study together with a new project ENDxTB, which aims to evaluate new diagnostics for incident, active, and recurrent TB. By comparing an array of novel TB tests, ENDxTB will identify the best tests for diverse situations and patient groups.

ENDxTB will receive €6.4 million from the US National Institutes of Health over 5 years

Both TriageTB and ENDxTB are managed by LINQ and coordinated by Stellenbosch University, represented by Prof Gerhard Walzl. Prof Walzl is leading ENDxTB together with the two other main Principal Investigators, Dr Jayne Sutherland (MRC Unit The Gambia at LSHTM) and Prof John Belisle (Colorado State University).

"Our goal is to conduct a global clinical project to compare side-by-side the most-promising new TB tests for various health care settings. We have included experienced clinical sites in Africa (South Africa, The Gambia and Uganda) and Vietnam, and laboratories in the USA and Europe, to test the performance of novel TB assays in cohorts that include adults, children, and people living with HIV and type-2 diabetes," Prof Walzl said in a press release about the launch of ENDxTB by Stellenbosch University.

Nearly 4,000 participants will be included in the large-scale study

ENDxTB is funded by the US National Institutes of Health (NIH) from which it will receive €6.4 million in funding over five years and enrol nearly 4,000 participants.

The project will look at the effects of diabetes and HIV on the TB tests as diseases change immune responses which could change the host signatures.

“It will be important to have a signature robust enough to not be adversely affected by HIV and diabetes," Prof Walzl explained in the press release.

There are also plans to look at the ability of the tests to differentiate between TB and COVID-19 infections.

ENDxTB project partners: ‍

• Stellenbosch University

• South African Tuberculosis Vaccine Initiative, UCT

• MRC Unitthe Gambia at LSHTM

• Oxford University Clinical Research Unit, Vietnam

• ColoradoState University

• Leiden University Medical Center

• LINQ management GmbH

ENDxTB and TriageTB project consortia will collaborate on multiple levels, for example by aligning their clinical trial activities. Joint working groups have already been established to enable the consortia to coordinate activities in the main fields of work.