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NCT05305534 | Not yet 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 : November 2023
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : August 2024

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

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QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study

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