Validation of New Microfluidic and Lateral Flow Diagnostic Tests for Detecting Respiratory Infections in Children and Adults Across Multiple Sites in Africa

What this Trial Is About

Researchers are evaluating new diagnostic technologies designed to detect upper and lower respiratory tract infections in both children and adults presenting with respiratory symptoms in Uganda, Ethiopia, and Senegal. This observational study aims to assess whether the novel lateral flow tests and microfluidic point-of-care platforms have sufficient accuracy and whether they are practical for use in low-resource clinical settings. The study is conducted across multiple sites and includes participants with suspected respiratory infections, such as fever, cough, or difficulty breathing. The study consists of two sub-studies. The first focuses on upper respiratory infections and evaluates a multiplex lateral flow test detecting influenza, RSV, and COVID-19 from nasal swabs, with results read visually and via an Android tablet. The second sub-study assesses a point-of-care instrument using microfluidic technology to detect bacterial and fungal pathogens in lower respiratory infections, comparing results with standard laboratory methods. Participants provide respiratory and blood samples, and some adults and community members complete surveys about sample biobanking and diagnostic acceptance. Participants attend a single study visit during which respiratory and blood samples are collected for testing and future research. Clinical and demographic information is gathered, and some participants complete surveys or interviews about biobanking acceptability. The study measures diagnostic accuracy and feasibility of the new tests compared to reference methods. Routine medical care continues unchanged, and the study includes participants aged 6 months and older. The trial aims to complete in mid-2026.

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