SeroSelectTB
SeroSelectTB is a multinational project coordinated by the Norwegian Institute of Public Health.
About the project
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Project period: 01.01.2020 - 31.12.2025 (Concluded)
- Coordinating Institution: Norwegian Institute of Public Health
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Project Manager:
- Carol Joanne Church Holm-Hansen, Norwegian Institute of Public Health
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Project Participants:
- Aida Babaii, Researc Administrative Support
- Ida Laake, Infection Control
- Grant Theron, Stellenbosch University
- Balthazar Nyombi, KCMC University
- Kidist Bobosha, AHRI Armauer Hansen Research Institute
- Kristin Kremer, KNCV Tuberculosisfoundation
- Nick Borain, Lateral Flow Laboratories (Pty) Ltd
- Tim Welsink, InVivo Biotech Services GmbH
- Aleksandar Josifoski, Aether Dynamics Consulting and Trading GmbH
- Miloje Savic, Aether Dynamics Consulting and Trading GmbH
Summary
The performance of a new triage test for active tuberculosis, SeroSelectTB, was qualified in a multi-centre randomised controlled trial at health-posts in South Africa, Tanzania and Ethiopia. Cost effectiveness was adressed to support a value proposition to stakeholders and regulatory authorities, and to support commercialization requirements. Consenting adults provided blood samples for screening by SeroSelectTB, and sputum was collected for routine TB diagnosis by the health services. Clinical and sociodemographic information was collected. A reliable rapid test will make it possible to identify and selectively treat those with active TB at the local healthcare level. The expected impact was accurate same-day diagnosis of patients with active TB, reduction in diagnostic delay and TB transmission, and diagnostic cost-savings for patients and healthcare systems in high burden countries. The use of SeroSelectTB was associated with earlier treatment initiation among individuals with TB. The study demonstrated that triage-based diagnostic strategies can be integrated within routine primary healthcare systems without disrupting routine pathways. Rapid triage tools may be suitable in decentralized, community-based, and in-home testing models, where they can identify individuals and households requiring additional diagnostic evaluation. The low cost, short turnaround time, simplicity of the procedure, and non-cold chain requirement make SeroSelectTB well suited for use at primary healthcare settings with minimal infrastructure. The lack of a rapid screening test at the primary healthcare level resulted in a significant use of expensive confirmatory tests with limited return in investment per positive TB case detected. SeroSelectTB was a multinational project coordinated by the Norwegian Institute of Public Health (Oslo, Norway). Partners include Stellenbosch University and Lateral Flow Laboratories (South Africa), KCMC University (Tanzania), Armauer Hansen Research Institute (Ethiopia), KNCV Tuberculosis Foundation (Netherlands), InVivo Biotech Services GmbH (Germany), and Aether Dynamics Consulting & Trading GmbH (Austria).