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.
Who can participate
Age range
6 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 6 months
* Presentation with suspected respiratory tract infection and at least two of the following symptoms:
* Fever (axillary temperature ≥37.5°C) or history of fever
* New acute cough episode
* Shortness of breath
* Tachypnoea (fast breathing)
* Loss of smell and/or taste
* Ability to provide written informed consent (or assent with parent/guardian consent for minors)
* For infants (≤1 year), both fever and new acute cough must be present at screening
Exclusion Criteria:
* 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
* Acute injury, trauma, or poisoning interfering with participation
* Chronic cough lasting \>2 weeks, unless tuberculosis is suspected in the LRTI cohort
* Antibiotic use within the previous 2 weeks for participants enrolled in the LRTI cohort (Sub-study 2) only
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.