Collection of Nasal Swabs, Throat Swabs and Saliva Samples from patients presenting at their designated care or testing facility displaying symptoms of either Influenza, Respiratory Syncytial Virus (RSV), SARS-CoV-2 or those who have been in recent contact with SARS-CoV-2 positive patients. Collected samples will aid the development, calibration and performance evaluation of the LumiraDx POC Test.
INFORM is a sample collection study targeting a population of patients attending their designated care or testing facility, suspected of having a respiratory illness typical of Influenza, RSV or COVID-19 and undergoing a Standard of Care (SOC) test on the day. Or those who have been in recent contact with SARS-CoV-2 positive patients. Participants may be of any age, there is no upper or lower age limit. Depending on the facility's viability and agreed contracting, the following study samples will be collected per patient: Adult Population: Two (2) Nasal, AND/OR Two (2) Throat Swabs AND/OR, One (1) Saliva Sample Paediatric Population: Two (2) Nasal, OR Two (2) Throat Swabs AND/OR, One (1) Saliva Sample Once required samples and data have been collected, participation is complete. No follow-up or subsequent patient involvement is required.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
2,500
Sample Collection - Adult Population: * Two (2) Nasal AND/OR * Two (2) Throat Swabs AND/OR * One (1) Saliva Sample Sample Collection - Paediatric Population: * Two (2) Nasal OR * Two (2) Throat Swabs AND/OR * One (1) Saliva Sample
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
NHS Lothian - Royal Hospital for Children & Young People
Edinburgh, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
Barts Health NHS Trust
London, United Kingdom
University College London Hospitals NHS Foundation Trust
London, United Kingdom
St George's University Hospitals NHS Foundation
London, United Kingdom
Collection of Nasal Swabs, Throat Swabs and Saliva Samples across a range of demographics.
The collection of Nasal Swabs, Throat Swabs and Saliva Samples positive for Influenza A, Influenza B, RSV or SARS-CoV-2 across a range of demographics to help determine the accuracy of the LumiraDx Point of Care (POC) Influenza A/B + RSV and SARS-CoV-2 tests.
Time frame: 1-3 Years
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