Project: Evaluation of host biomarker-based point-of-care tests for targeted screening for active TB

Acronym Screen TB (Reference Number: DRIA2014-311)
Duration 01/04/2016 - 31/03/2019
Project Topic New recommendations regarding screening for active TB have been formulated and these include a focus on high TB prevalence areas, people living with HIV infection and populations with difficult access to efficient TB diagnostic services, such as access to current gold-standard tests like the GeneXpert test. Such tests are still mainly conducted in a centralized manner in laboratories or in larger health care facilities and are therefore not accessible to many patients who are living in remote settings. As sputum samples, used to diagnose TB, need to be transported to the central facilities, there is a diagnostic delay, often lasting several days. During such delays many patients are never started on treatment as they become lost to follow up. The Screen TB project builds on extensive experience gained during EDCTP I and is based on strong and very promising data on the levels of several proteins that are associated with inflammation in a patient’s blood. Levels of these proteins are different in TB versus other lung diseases. Furthermore, we have in-depth experience in the consortium with point-of-care (POC) implementation of user-friendly tests, similar to strip tests for measuring blood glucose levels. The type of test for TB screening in this project is called a lateral flow assay (LFAs). The study addresses the important topic of screening for active TB, which would significantly speed up and streamline diagnostic approaches in resource-limited settings. We have identified a six-marker diagnostic signature for active TB with sensitivity of 94% and specificity of 74%, regardless of HIV status and are testing this signature through rapid, laboratory-free point-of-care LFAs with the capability to measure multiple markers simultaneously. The proposed LFA device utilizes novel, nano-sized reporter particles called upconverting phosphor (UCP) reporter particles with excellent sensitivity and robustness. The LFA can be adapted for measurement of markers in finger-prick blood, which will further enhance its point-of-care utility. Our non-interventional trial is recruiting 800 adults people with symptoms suggestive of active TB, regardless of HIV infection status, and across five African countries. UCP-LFA test results will be compared to gold standard tests and established project-specific case definitions. The successful implementation of a sensitive, cost effective screening test with performance similar to our current biosignature would streamline diagnostic programs in resource-limited settings and could decrease unnecessary referrals for GeneXpert testing by 75%. Additionally, we will continue to build significant African clinical trial capacity by hosting workshops on clinical trial and laboratory procedures during our annual meetings and by supporting the promising early and mid-career African scientists through a mentorship program and by improving South-South and South-North networking. More information about the project and its progress is available on the Screen TB website.
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Network EDCTP2
Call Research & Innovation Action: Diagnostic tools for poverty-related diseases

Project partner

Number Name Role Country
1 Stellenbosch University Coordinator South Africa
2 Academisch Ziekenhuis Leiden Partner Netherlands, The
3 Makerere University Partner Uganda
4 Armauer Hansen Research Institute Partner Ethiopia
5 Medical Research Council Partner United Kingdom
6 University of Namibia Partner Namibia
7 London School of Hygiene and Tropical Medicine Partner United Kingdom
8 European Research and Project Office GmbH Partner Germany
9 LINQ Management GmbH Partner Germany