QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study

Blood Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05305534
• Other study ID #: SMF-18-0136-1-001
• Status: Not yet recruiting
• Start date: November 2023
• Est. completion date: August 2024

Study information

• Verified date: October 2023
• Source: QIAGEN Gaithersburg, Inc
• Contact: Sarah Johnson
• Phone: 0161 232 6814
• Email: Sarah.Johnson[@]qiagen.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2880
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Disease
• Hematologic Diseases

Intervention

Device:
• QIAstat-Dx® BCID GN and GPF Plus AMR Panels
The performance of QIAstat-Dx® BCID GN and GPF Plus AMR Panels will be evaluated in comparison with another validated comparator method, using residual specimens of positive blood culture. Pure colonies derived from the residual positive blood culture specimens will also be tested

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
QIAGEN Gaithersburg, Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PPA	positive percentage agreement	6 moths
Primary	NPA	negative percentage agreement	6 moths