Grant Success for the Evaluation of Host Biomarker-Based Point-of-Care Tests for Targeted Screening for Active Tuberculosis (TB)

Dr Jayne Sutherland, Head TB Immunology Group, has recently been awarded a grant funded by European & Developing Countries Clinical Trials Partnership (EDCTP) on April 1, 2016.The consortium is lead by Prof Gerhard Walzl of Stellenbosch University – South Africa. The project, “Evaluation of host biomarker-based point-of-care tests for targeted screening for active TB”, is valid for a period of 3 years.

The project 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 the sensitivity of 89% and specificity of 75%. Regardless of HIV status, the proposal is to implement testing of this signature through rapid, laboratory-free point-of-care (POC) lateral flow assays (LFAs) with the capability to measure multiple markers simultaneously.

This initiative builds on our extensive experience gained during EDCTP, based on strong and promising host biomarker data and on in-depth experience with POC implementation of user-friendly LFAs. The screen TB project will 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 GeneXpert testing.

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Dr Jayne Sutherland, Head TB Immunology Group

According to Dr Jayne Sutherland, “This is an exciting project, extending our previous multi-site collaboration with the aim of generating a commercially viable, point-of-care test for diagnosing TB in developing countries. All the sites (South Africa, Gambia, Malawi, Namibia and Ethiopia) have previously worked together. Our findings,“Diagnostic Performance of a Seven-marker Serum Protein Biosignature for the Diagnosis of Active TB Disease in African Primary Health Care Clinic Attendees with Signs and Symptoms Suggestive of TB”, have recently been published in Thorax. The present study will allow us to confirm our findings using a novel ‘immunodot’ technique to test multiple host factors with a small volume of blood.”

The study will start in September 2016 and will be conducted in collaboration with the National Leprosy and Tuberculosis Programme through the Ministry of Health and Social Welfare.