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

Covid19 Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Influenza Type A
• Influenza Type B
• Influenza, Human
• Respiratory Syncytial Virus Infections
• RSV Infection

• NCT number: NCT04782336
• Study type: Interventional
• Source: LumiraDx UK Limited
• Status: Suspended
• Phase: N/A
• Start date: December 12, 2020
• Completion date: June 30, 2024