Status:
COMPLETED
QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study
Lead Sponsor:
QIAGEN Gaithersburg, Inc
Conditions:
Blood Disease
Eligibility:
All Genders
Brief 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.
Eligibility Criteria
Inclusion
- Positive (as identified through Gram stain) blood culture media specimens cultured within bottle types listed in IFU.
- Residual and de-identified specimens.
- Specimen from subject who has not previously been enrolled.
- Fresh prospectively collected specimens tested within 24 hours of initial blood culture bottle positivity.
- Frozen prospectively collected specimens frozen within 24 hours of initial blood culture bottle positivity.
- Minimum 1.5 mL volume available
- In stage 2 - Pure colony isolates of Bacilli, Actinobacteria, fungi (except Fusarium), Enterobacterales, Pseudomondales, Nesseriales, Pasteurellales, Bacterioidales, or Xanthomonadales.
Exclusion
- Positive Blood Culture specimens inoculated with a sample type other than Blood (i.e. Paracentesis, or other body fluids)
- Specimens collected off-label from the manufacturer's package insert (e.g., less than the minimum required blood volume was collected).
- Frozen specimens which are unable to be cultured after thawing.
- Specimen from subject previously enrolled
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 25 2025
Estimated Enrollment :
2142 Patients enrolled
Trial Details
Trial ID
NCT05305534
Start Date
December 1 2023
End Date
August 25 2025
Last Update
September 24 2025
Active Locations (1)
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1
QIAGEN
Manchester, United Kingdom