Study for Multiplex Assessment and Respiratory Test evaluation; SMART
Research type
Research Study
Full title
Evaluation of Digital Microfluidic Molecular Point of Care Testing for Diagnosis of Respiratory Pathogens
IRAS ID
363005
Contact name
Adrian Boyle
Contact email
Sponsor organisation
Logilet (UK) Ltd
Duration of Study in the UK
0 years, 3 months, 31 days
Research summary
When a patient presents to a hospital Emergency Department (ED) with symptoms of respiratory infection, the time taken to make a diagnosis and start appropriate treatment can influence the patient's outcome; the quicker the treatment is commenced, the better the outcome for the patient and the more efficiently patients can be isolated to stem the spread of infection. This study aims to evaluate the accuracy and timelines for a new device, compared to the gold standard device, for diagnosing respiratory pathogens. This is a performance evaluation study of the new device and will not affect the treatment participants receive in the ED. Males and females of any age, with clinical symptoms of respiratory infection and an age-appropriate signed consent form will be recruited to the study. Participants are simply required to have an extra nasopharyngeal swab, compared to the standard care pathway. Pseudonymised data will be collected for trial analysis. The study will be performed over a 3-4 month period (winter months) when respiratory infections are prevalent.
REC name
West of Scotland REC 4
REC reference
25/WS/0171
Date of REC Opinion
14 Nov 2025
REC opinion
Favourable Opinion