QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study

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

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

Study Overview

• Status: Completed
• Conditions: Blood Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 2142

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom
    • QIAGEN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients suspected of bloodstream infection

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PPA	positive percentage agreement	6 moths
NPA	negative percentage agreement	6 moths

Collaborators and Investigators

• Sponsor: QIAGEN Gaithersburg, Inc
• Investigators: Principal Investigator: Sarah Johnson, QIAGEN Gaithersburg, Inc

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): April 10, 2025
• Study Completion (Actual): August 25, 2025

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hemic and Lymphatic Diseases; Hematologic Diseases
• Other Study ID Numbers: SMF-18-0136-1-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: all samples are residual and anonymized

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No