Trials / Completed
CompletedNCT05305534
QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study
Clinical Performance Evaluation Study of the QIAstat-Dx® BCID GN and GPF Plus AMR Panels on Positive Blood Culture and Pure Colony Isolates From Subjects With Signs and Symptoms of Bloodstream Infection
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,142 (actual)
- Sponsor
- QIAGEN Gaithersburg, Inc · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Study for performance evaluation of the QIAstat-Dx® BCID Plus AMR GPF-Panel and the QIAstat Dx® BCID Plus AMR GN-Panel in comparison with other chosen comparator methods
Detailed description
This multicenter study aims to evaluate the performance of QIAstat-Dx® BCID Plus AMR GPF-Panel and the QIAstat Dx® BCID Plus AMR GN-Panel with another validated comparator method.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | QIAstat-Dx® BCID GN and GPF Plus AMR Panels | The performance of QIAstat-Dx® BCID GN and GPF Plus AMR Panels will be evaluated in comparison with another validated comparator method, using residual specimens of positive blood culture. Pure colonies derived from the residual positive blood culture specimens will also be tested |
Timeline
- Start date
- 2023-12-01
- Primary completion
- 2025-04-10
- Completion
- 2025-08-25
- First posted
- 2022-03-31
- Last updated
- 2025-09-24
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT05305534. Inclusion in this directory is not an endorsement.