Trials / Completed
CompletedNCT05155553
QIAstat-Dx® Meningitis/Encephalitis Panel Performance Evaluation Study
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,524 (actual)
- Sponsor
- QIAGEN Gaithersburg, Inc · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Study for performance evaluation of the QIAstat-Dx® Meningitis/Encephalitis Panel in comparison with other chosen comparator methods.
Detailed description
This multicenter study aims to evaluate the performance of QIAstat-Dx Meningitis/Encephalitis (ME) Panel with another validated comparator method.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | QIAstat-Dx® Meningitis/Encephalitis (ME) Panel | The performance of QIAstat-Dx® Meningitis/Encephalitis Panel will be evaluated in comparison with another validated comparator method, followed by bidirectional sequencing using residual specimens of cerebrospinal fluid (CSF) obtained by lumbar puncture from subjects with signs and symptoms of meningitis and/or encephalitis. |
Timeline
- Start date
- 2022-05-04
- Primary completion
- 2023-03-02
- Completion
- 2023-03-02
- First posted
- 2021-12-13
- Last updated
- 2024-10-17
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT05155553. Inclusion in this directory is not an endorsement.