Clinical Research Directory

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

Sponsor: Karolinska Institutet

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.

Official title: Clinical Validation of Novel Microfluidic and Lateral Flow-based Technologies for the Detection of Lower and Upper Respiratory Tract Infections - HOLICARE Trial

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Locations (3)