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NCT05305534 | RECRUITING | Blood Disease

QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study
Sponsor:

QIAGEN Gaithersburg, Inc

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

Condition or disease

Blood Disease

Intervention/treatment

QIAstat-Dx® BCID GN and GPF Plus AMR Panels

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 2880 participants
Official Title : 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
Actual Study Start Date : 2023-12-01
Estimated Primary Completion Date : 2025-07
Estimated Study Completion Date : 2025-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study

Location Details

NCT05305534

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United Kingdom,

QIAGEN

Manchester, United Kingdom,