QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study (NCT05305534) | Clinical Trial Compass
CompletedNot Applicable
QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study
United Kingdom2,142 participantsStarted 2023-12-01
Plain-language 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
Who can participate
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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