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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05305534

Enrollment

2142

Registered

2022-03-31

Start date

2023-12-01

Completion date

2025-08-25

Last updated

2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Disease

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.

Interventions

DEVICEQIAstat-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

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026