INFORM
Research type
Research Study
Full title
Sample Collection to Facilitate the Performance Evaluation of the LumiraDx Point of Care Device for the Detection of Influenza A/B and Respiratory Syncytial Virus (RSV)
IRAS ID
276304
Contact name
Samer Elkhodair
Contact email
Duration of Study in the UK
1 years, 3 months, 31 days
Research summary
This is a sample collection protocol in a population of patients attending Outpatient or Emergency Department/Clinics with symptoms of respiratory illness typical of influenza or RSV (coughing, wheezing, high temperature etc).
Influenza and Respiratory Syncytial Virus (RSV) cause thousands of people to become ill each year. Young children are especially prone to infection with RSV. Since the signs and symptoms are similar between respiratory illnesses, making a clear diagnosis by the attending clinician can be difficult. A rapid and accurate test conducted near to the patient giving a clear positive or negative result can enable a faster diagnosis, reduce the overuse of antibiotics and enable prompt and appropriate treatment to be administered.
Participants (or their parent/guardian) who consent to this study will be agreeing to have two study samples collected (this will either be two throat, or two nasal swabs). These samples will then be transferred to LumiraDx for use in their performance testing of the LumiraDx influenza A/B & RSV assay.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
20/NE/0019
Date of REC Opinion
13 Feb 2020
REC opinion
Favourable Opinion