The performance of a new triage test for active tuberculosis, SeroSelectTB, will be qualified in multi-centre randomised controlled trials at health-posts in South Africa, Tanzania and Ethiopia.
The performance of a new triage test for active tuberculosis, SeroSelectTB, will be qualified in multi-centre randomised controlled trials at health-posts in South Africa, Tanzania and Ethiopia. Cost effectiveness evaluations will be conducted to support a value proposition to stakeholders and regulatory authorities, and to support commercialization requirements. Consenting adults will provide blood and saliva samples for screening by SeroSelectTB, and sputum collected for routine TB diagnosis by the health services. Clinical and sociodemographic information will be 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 includes accurate same-day diagnosis of patients with active TB, reduction of diagnostic delay and TB transmission, and diagnostic cost-savings for patients and healthcare systems in high burden countries.
SeroSelectTB is a multinational project coordinated by the Norwegian Institute of Public Health (Oslo, Norway). Partners include Stellenbosch University and Lateral Flow Laboratories (South Africa), Kilimanjaro Christian Medical University College (Tanzania), Armauer Hansen Research Institute (Ethiopia), National Institute for Public Health and the Environment (Netherlands), InVivo Biotech Services GmbH (Germany), Aether Dynamics Consulting & Trading GmbH (Austria), and E-MEDDIA (France).
Carol Joanne Church Holm-Hansen, Folkehelseinstituttet
Tara Kelly Dolgner, Avdeling for forskningsadministrativ støtte, Folkehelseinstituttet
Ida Laake, Smittevern, Folkehelseinstituttet
Grant Theron, Universiteit Stellenbosch
Anna Ojo, Universiteit Stellenbosch
Balthazar Nyombi, Kilimanjaro Christian Medical University College
Kidist Bobosha, AHRI Armauer Hansen Research Institute
Kristin Kremer, Rijksinstituut voor Volksgezondheid en Milieu
Nick Borain, Lateral Flow Laboratories (Pty) Ltd
Tim Welsink, InVivo Biotech Services GmbH
Aleksandar Josifoski, Aether Dynamics Consulting and Trading GmbH
Fatima Gruszka, E-MEDDIA
Miloje Savic, E-MEDDIA
European and Developing Countries Clinical Trials Partnership (EDCTP) grant code: RIA2018D-2493
Regionale komitéer for medisinsk og helsefaglig forskningsetikk (REK)
YTTERLIGE DELTAGERE: Byron Reeve – Stellenbosch University • Shima Abdulgader – Stellenbosch University • Julianne du Plessis - Lateral Flow Laboratories • Saumu Pazia Juma - Kilimanjaro Clinical Research Institute • Tamirat Assefa - Armauer Hansen Research Institute • Solomon Yimer - Armauer Hansen Research Institute