QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study
NCT ID: NCT05305534
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2142 participants
OBSERVATIONAL
2023-12-01
2025-08-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
ALL
No
Sponsors
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QIAGEN Gaithersburg, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Sarah Johnson
Role: PRINCIPAL_INVESTIGATOR
QIAGEN Gaithersburg, Inc
Locations
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QIAGEN
Manchester, , United Kingdom
Countries
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Other Identifiers
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SMF-18-0136-1-001
Identifier Type: -
Identifier Source: org_study_id
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