The problem

Tuberculosis (TB) places severe pressure on health care services of the developing world. According to the WHO, 1.5 million people were killed by TB in 2014. It now ranks alongside HIV as a leading cause of death worldwide. In 2014, the African Region accounted for 74% of those cases, in which people were affected by both TB and HIV, according to the WHO. It is crucial for people who are affected by both HIV and TB to be reliably diagnosed with the latter, because the tuberculosis skin test can be compromised by HIV. The high burden of undiagnosed TB fuels on-going transmission and poor treatment outcomes. Many people in high TB prevalence areas still do not have access to efficient TB diagnostic services due to logistical constraints that plague these settings.

The goal

The overall objective of the study is to incorporate the six-marker signature into a multiplex UCP-LFA format, referred to as TransDot, for finger-prick blood testing. The end point of the study is the accuracy (sensitivity and specificity) of the UCP-LFA TransDot test on finger-prick blood for active TB and will be prospectively compared against gold standard composite diagnostic criteria (GeneXpert, MGIT culture, TB sputum smear, CXR, TB symptom screen and response to TB treatment).

The implementation phase

WP 1 will focus on the optimization and production of the new screening test for active TB in the laboratory

The validation and qualification of the biomarker test will be conducted on samples already available plus on samples from the prospective cohorts of participants with suspected active TB.

To increase ease and allow rapid diagnosis, the TransDot will be applied to point-of-care (POC) using finger-prick blood rather than venous blood. This will avoid the need of a trained phlebotomist; reduce cost and amount of blood required. Thus, it will enable the conduction of the assays in a laboratory-free manner, thereby eliminating the need for transportation of samples and speeding up the diagnostic work-up process.

The Multi-Biomarker Test

The main clinical study

WP 2 will constitute a non-interventional clinical trial that will be conducted to evaluate and if necessary optimize the TransDot screening test for active TB.

WP 2 will evaluate the assay performance on prospective cohorts in high TB prevalence sites in Africa

Capacity Building and mentorship

To contribute effectively to solving its health challenges, Africa needs a highly trained cadre of researchers, able to initiate and lead research projects and to manage them effectively so that milestones and deliverables are achieved and resources managed appropriately. Scientific research is also now performed most efficiently within research consortia, and young scientists need to learn to maximise the opportunities that networking offers. Developing their own networks, based on good project visibility, will provide them with a personal support structure as their careers progress. To achieve these goals, the young scientists need mentorship and advice to develop their own personal development plans.

Screen TB’s WP 3 will focus on capacity building and networking and will strive to establish young African scientists as independent researchers and enhance the strong track records of the African partners.

A mentorship program, during which senior academics in the consortium will mentor early and mid-career scientists through regular electronic, telephonic, Skype and face-to-face meetings, and a capacity building program that encompasses the full spectrum of clinical research activities will be implemented. Individual personal development plans for young researchers will be introduced.