Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 4:59 AM
Study NCT ID:
NCT06820060
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Performance of QIAstat-Dx® Meningitis/Encephalitis (ME) Panel Plus
Sponsor:
QIAGEN Gaithersburg, Inc
Organization:
Study Overview
Official Title:
An Observational, Prospective and Retrospective Clinical Study to Evaluate the Performance of QIAstat-Dx® Meningitis/Encephalitis (ME) Panel Plus During Normal Conditions of Use
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-04
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:
Performance evaluation of QIAstat-Dx® ME Panel Plus using the QIAstat-Dx® Analyzer to demonstrate that the QIAstat-Dx® ME Panel Plus achieves its intended performance during normal conditions of use by the intended user in the intended environment
Detailed Description:
The objective of the study is to demonstrate that the QIAstat-Dx® ME Panel Plus achieves its intended performance during normal conditions of use by the intended user in the intended environment.
The primary objective is to evaluate the performance of QIAstat-Dx® ME Panel Plus in comparison with the results obtained from the reference method.
The secondary objective of the study is to evaluate the safety of QIAstat-Dx® ME Panel Plus with respect to users/operators.
The primary study endpoint will be the results for each analyte obtained from testing prospective and retrospective specimens with QIAstat-Dx® ME Panel Plus and Reference Method. Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) will be determined
The primary objective is to evaluate the performance of QIAstat-Dx® ME Panel Plus in comparison with the results obtained from the reference method.
The secondary objective of the study is to evaluate the safety of QIAstat-Dx® ME Panel Plus with respect to users/operators.
The primary study endpoint will be the results for each analyte obtained from testing prospective and retrospective specimens with QIAstat-Dx® ME Panel Plus and Reference Method. Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) will be determined
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?: