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QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study

Sponsor
QIAGEN Gaithersburg, Inc (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05305534
Collaborator
(none)
2,880
Enrollment
6
Anticipated Duration (Months)

Study Details

Study Description

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 Intervention/Treatment Phase
  • Device: 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 Design

Study Type:
Observational
Anticipated Enrollment :
2880 participants
Observational Model:
Other
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Outcome Measures

Primary Outcome Measures

  1. PPA [6 moths]

    positive percentage agreement

  2. NPA [6 moths]

    negative percentage agreement

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • QIAGEN Gaithersburg, Inc

Investigators

  • Principal Investigator: Sarah Johnson, QIAGEN Gaithersburg, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
QIAGEN Gaithersburg, Inc
ClinicalTrials.gov Identifier:
NCT05305534
Other Study ID Numbers:
  • SMF-18-0136-1-001
First Posted:
Mar 31, 2022
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hematologic Diseases

Study Results

No Results Posted as of Mar 31, 2022