About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 6 months
Fever (axillary temperature ≥37.5°C) or history of fever
New acute cough episode
Shortness of breath
Disqualifiers
Refusal or inability to provide informed consent/assent
Refusal to provide study samples
Severe chronic medical conditions or mental incapacity that, in the opinion of the clinician, would interfere with study participation
Hospitalisation within the previous 2 weeks for reasons unrelated to the current respiratory symptoms
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Karolinska Institutet
Lead sponsor
KTH Royal Institute of Technology
Collaborator
Institut Pasteur, Dakar, Sénégal
Collaborator
Armauer Hansen Research Institute, Ethiopia
Collaborator
Epicentre Mbarara Research Center
Collaborator
Global Access Diagnostics (GADx)
Collaborator
MAST Diagnostica Gmbh
Collaborator
Makerere University
Collaborator
Hahn Schickard
Collaborator
Teesside University
Collaborator
BLUMORPHO SAS
Collaborator
iSTOC OY
Collaborator
University of Freiburg
Collaborator
Stockholm University
Collaborator