Evaluation of QIAstat-Dx® BCID Plus AMR Panels for Blood Disease
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
This study is testing if new blood testing panels can accurately identify infections in people with blood diseases compared to current methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2880 (estimated) |
| Sex | All |
| Sponsor | QIAGEN Gaithersburg, Inc Industry-sponsored |
| Locations | 1 site (Manchester) |
| Trial ID | NCT05305534 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the performance of the QIAstat-Dx® BCID Plus AMR GPF-Panel and the QIAstat-Dx® BCID Plus AMR GN-Panel in comparison to other validated methods. It involves multicenter participation and focuses on analyzing blood culture specimens that test positive for specific pathogens. The study aims to assess the accuracy and reliability of these panels in diagnosing blood diseases.
Who should consider this trial
Good fit: Ideal candidates include individuals with positive blood culture specimens identified through Gram stain.
Not a fit: Patients with positive blood culture specimens from non-blood sources or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of diagnosing blood infections, leading to better-targeted treatments for patients.
How similar studies have performed: Other studies have shown success in evaluating diagnostic panels for blood infections, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Manchester
- Qiagen — Manchester, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Sarah Johnson — QIAGEN Gaithersburg, Inc
- Study coordinator: Sarah Johnson
- Email: Sarah.Johnson@qiagen.com
- Phone: 0161 232 6814
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.