QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study

NCT05305534 | Completed

• 1 other identifier: SMF-18-0136-1-001
• Study Type: observational
• Target: 2,142
• Locations: 1 country
• Sites: 1

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

Conditions

Blood Disease

Outcome Measures

Primary Outcomes (2)

• PPA

  positive percentage agreement

  6 moths

• NPA

  negative percentage agreement

  6 moths

Interventions

QIAstat-Dx® BCID GN and GPF Plus AMR Panels DEVICE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suspected of bloodstream infection

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• QIAGEN Gaithersburg, Inc: lead

Study Sites (1)

QIAGEN

Manchester, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

positive blood culture clinical samples and pure colony samples

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

• Sarah Johnson

  QIAGEN Gaithersburg, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: December 1, 2023
• Primary Completion: April 10, 2025
• Study Completion: August 25, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)