Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04782336
Status:
SUSPENDED
Last Update Posted:
2024-01-26
First Post:
2021-02-17
Brief Title:
Sample Collection Study to Aid Evaluation of an Influenza AB Respiratory Syncytial Virus COVID-19 Virus POC Test
Sponsor:
LumiraDx UK Limited
Organization:
LumiraDx UK Limited
Study Overview
Official Title:
Sample Collection to Facilitate the Performance Evaluation of the LumiraDx Point of Care Device for the Detection of Influenza AB Respiratory Syncytial Virus RSV COVID-19 SARS-COV-2 Virus
Status:
SUSPENDED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment Pause
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INFORM
Brief 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 facilitys viability and agreed contracting the following study samples will be collected per patient
Adult Population Two 2 Nasal ANDOR Two 2 Throat Swabs ANDOR One 1 Saliva Sample
Paediatric Population Two 2 Nasal OR Two 2 Throat Swabs ANDOR One 1 Saliva Sample
Once required samples and data have been collected participation is complete No follow-up or subsequent patient involvement is required
Depending on the facilitys viability and agreed contracting the following study samples will be collected per patient
Adult Population Two 2 Nasal ANDOR Two 2 Throat Swabs ANDOR One 1 Saliva Sample
Paediatric Population Two 2 Nasal OR Two 2 Throat Swabs ANDOR 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None