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

Summary

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.

Conditions

• Upper Respiratory Infection
• Lower Resp Tract Infection

Sponsors & Collaborators

• KTH Royal Institute of Technology

  collaborator OTHER

• Institut Pasteur, Dakar, Sénégal

  collaborator UNKNOWN

• Armauer Hansen Research Institute, Ethiopia

  collaborator OTHER

• Epicentre Mbarara Research Center

  collaborator UNKNOWN

• Global Access Diagnostics (GADx)

  collaborator UNKNOWN

• MAST Diagnostica Gmbh

  collaborator UNKNOWN

• Makerere University

  collaborator OTHER

• Hahn Schickard

  collaborator UNKNOWN

• Teesside University

  collaborator OTHER

• BLUMORPHO SAS

  collaborator UNKNOWN

• iSTOC OY

  collaborator UNKNOWN

• University of Freiburg

  collaborator OTHER

• Stockholm University

  collaborator OTHER

• Karolinska Institutet

  lead OTHER

Principal Investigators

• Aman Russom, PhD · KTH Royal Institute of Technology

• Juliet Mwanga-Amumpaire, MD, PhD · Epicentre Mbarara Research Centre

• Adane Mihret, DVM, MSc, PhD · Armauer Hansen Research Institute, Ethiopia

• Cheikh Fall, PhD · Institut Pasteur de Dakar

Eligibility

Min Age

6 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-07

Primary Completion

2026-06-22

Completion

2026-08-31

Countries

• Ethiopia
• Senegal
• Uganda

Study Locations