NCT04782336

Sample Collection Study to Aid Evaluation of an Influenza A/B, Respiratory Syncytial Virus & COVID-19 Virus POC Test

Sample Collection to Facilitate the Performance Evaluation of the LumiraDx Point of Care Device for the Detection of Influenza A/B, Respiratory Syncytial Virus (RSV) & COVID-19 (SARS-COV-2 Virus)

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,500 (estimated)
• Sponsor: LumiraDx UK Limited · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Covid19
• RSV Infection
• Influenza Type A
• Influenza Type B

Interventions

Type	Name	Description
OTHER	Sample Collection	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

Timeline

• Start date: 2020-12-12
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2021-03-04
• Last updated: 2024-01-26

Locations

6 sites across 1 country: United Kingdom