Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-26 @ 4:18 AM
Study NCT ID:
NCT05733559
Status:
COMPLETED
Last Update Posted:
2023-12-05
First Post:
2023-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
QIAstat-Dx® Respiratory Panel Plus (RPP) Clinical Performance Study
Sponsor:
QIAGEN Gaithersburg, Inc
Organization:
Study Overview
Official Title:
An Observational Prospective Clinical Study to Assess Clinical Performance of QIAstat-Dx® Respiratory Panel Plus (RPP) SARS-CoV-2 Target in the Intended Use Population and Environment
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:
This study will evaluate the clinical performance of the QIAstat-Dx® Respiratory Panel Plus (RPP) SARS-CoV-2 target with a validated comparator method
Detailed Description:
This multicentre study aims to evaluation the clinical performance of the QIAstat-Dx® Respiratory Panel Plus (RPP) SARS-CoV-2 target with a validated comparator method
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?: