Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05846360
Status:
COMPLETED
Last Update Posted:
2023-10-27
First Post:
2023-04-26
Brief Title:
The Technical and Operational Performance of the QuidelOrtho Savanna RVP4 Analyzer
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
The Technical and Operational Performance of the QuidelOrtho Savanna RVP4 Analyzer
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is for the research team to become familiar with and evaluate the technical and operational performance of the QuidelOrtho Savanna RVP4 analyzer by testing 120 archived specimens that were previously tested at the Wisconsin State Laboratory of Hygiene WSLH by RT-PCR and multiplex respiratory pathogen panel within the last year
Detailed Description:
To test the technical and operational performance of the QuidelOrtho Savanna RVP4 analyzer the investigator proposes to test samples archived from the ORegon CHild Absenteeism due to Respiratory Disease Study ORCHARDS study HSC 2013-1357 a study that had the goal to develop and implement a system for daily school-based monitoring of ILI influenza-like illness and CLI COVID-like illness student absenteeism in kindergarten K through grade 12 schools and assess the systems usability for early detection of accelerated influenza SARS-CoV-2 and other respiratory pathogen transmission in schools and surrounding communities
The deidentified paired WSLH vs Savanna RVP4 results will be used by QuidelOrtho Corporation to evaluate the technical and operational performance of the analyzer
The deidentified paired WSLH vs Savanna RVP4 results will be used by QuidelOrtho Corporation to evaluate the technical and operational performance of the analyzer
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SMPHFAMILY MEDCLINIC WINGRA | OTHER | UW Madison | None |