QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study

Qiagen

Status: Enrolling

Conditions: Blood Disease

Treatments: Device: QIAstat-Dx® BCID GN and GPF Plus AMR Panels

Study type: Observational

Funder types: Industry

Identifiers

NCT05305534

SMF-18-0136-1-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,880 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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