QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study | NCT05305534

Studies
QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study

NCT05305534

Sponsor

QIAGEN Gaithersburg, Inc

Status

Completed

Last Update Posted

Sep 24, 2025Actual

Enrollment

2,142Actual

Phase

Not provided

Conditions

Blood Disease

Interventions

QIAstat-Dx® BCID GN and GPF Plus AMR Panels

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Actual

Primary Completion Date

Apr 10, 2025Actual

Completion Date

Aug 25, 2025Actual

First Submitted Date

Mar 22, 2022

First Submission Date that Met QC Criteria

Mar 22, 2022

First Posted Date

Mar 31, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2025

Last Update Posted Date

Sep 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,142Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients suspected of bloodstream infection

Sampling Method

Probability Sample

Name	Affiliation	Role
Sarah Johnson	QIAGEN Gaithersburg, Inc	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

all samples are residual and anonymized

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided