QIAstat-Dx® Meningitis/Encephalitis Panel Performance Evaluation Study
Sponsor
QIAGEN Gaithersburg, Inc (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05155553
Collaborator
(none)
1,600
1
19.9
80.4
Study Details
Study Description
Brief Summary
Study for performance evaluation of the QIAstat-Dx® Meningitis/Encephalitis Panel in comparison with other chosen comparator methods.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This multicenter study aims to evaluate the performance of QIAstat-Dx Meningitis/Encephalitis (ME) Panel with another validated comparator method.
Study Design
Study Type:
Observational
Anticipated Enrollment
:
1600 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
An Observational Clinical Performance Evaluation Study Testing Residual Specimens of Cerebrospinal Fluid Obtained by Lumbar Puncture From Meningitis/Encephalitis Subjects Using the QIAstat-Dx® Meningitis/Encephalitis Panel
Actual Study Start Date
:
Jan 3, 2021
Anticipated Primary Completion Date
:
Aug 1, 2022
Anticipated Study Completion Date
:
Sep 1, 2022
Outcome Measures
Primary Outcome Measures
- PPA [6 months]
positive percentage agreement
- NPA [6 months]
negative percentage agreement
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Residual specimens (minimum 500μL) of CSF obtained by lumbar puncture from subjects with signs and symptoms of meningitis and/or encephalitis following completion of routine testing Specimen that have not undergone more than 3 freeze/thaw cycles.
Exclusion Criteria:
-
Specimens not fitting criteria outlined above.
-
CSF obtained from an external ventricular drain or shunt source.
-
Lack of clear subject identification or label on residual banked CSF specimen.
-
Specimen has been centrifuged.
-
Obvious physical damage of banked residual specimen.
-
Repeat specimens from the same subject.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Qiagen | Manchester | United Kingdom |
Sponsors and Collaborators
- QIAGEN Gaithersburg, Inc
Investigators
- Study Director: Sarah Johnson, QIAGEN Gaithersburg, Inc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
QIAGEN Gaithersburg, Inc
ClinicalTrials.gov Identifier:
NCT05155553
Other Study ID Numbers:
- SMF-DHF-18-0489-002
First Posted:
Dec 13, 2021
Last Update Posted:
Dec 13, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: