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

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

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.

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