Holistic Approach Supporting the Uptake of Innovative Diagnostic Technologies for Respiratory Infections

This observational diagnostic validation study aims to evaluate the clinical performance of novel lateral flow and microfluidic-based technologies for the detection of upper and lower respiratory tract infections in children and adults presenting with respiratory symptoms in Uganda, Ethiopia, and Senegal. The main questions it aims to answer are: 1. whether the novel multiplex lateral flow tests and point-of-care microfluidic platform demonstrate sufficient sensitivity and specificity for detecting respiratory pathogens compared with standard laboratory reference methods, and 2. whether these technologies are feasible and usable in low-resource clinical settings. Participants presenting with suspected respiratory tract infections as part of routine clinical care will provide respiratory and blood samples for diagnostic testing and biobanking, and demographic and clinical information will be collected during a single study visit. Some adult participants and community stakeholders will also complete surveys or interviews regarding the acceptability of biobanking and diagnostic implementation.

NCT Number	NCT07651865
Lead Sponsor	Karolinska Institutet Collaborators: KTH Royal Institute of Technology, Institut Pasteur, Dakar, Sénégal, Armauer Hansen Research Institute, Ethiopia, Epicentre Mbarara Research Center, Global Access Diagnostics (GADx), MAST Diagnostica Gmbh, Makerere University, Hahn Schickard, Teesside University, BLUMORPHO SAS, iSTOC OY, University of Freiburg, Stockholm University
Conditions	Upper Respiratory Infection, Lower Resp Tract Infection
Enrollment	2,160 participants
Start Date	2025-04-07
Primary Completion	2026-06-22 (estimated)
Study Completion	2026-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-29