Blood DiseaseNCT05305534
QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study
An observational study of Blood Disease, run by QIAGEN Gaithersburg, Inc at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blood Disease
- What is being tested?
- QIAstat-Dx® BCID GN and GPF Plus AMR Panels
- Type of treatment
- Medical device
- How many people
- 2,142 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2023to 25 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients suspected of bloodstream infection
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Blood Disease
- Being tested
- QIAstat-Dx® BCID GN and GPF Plus AMR Panels
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QIAstat-Dx® BCID GN and GPF Plus AMR PanelsDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
PPA
positive percentage agreement
Measured: 6 moths
NPA
negative percentage agreement
Measured: 6 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Dec 2023
- Primary completion10 Apr 2025
- Study completion25 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,142 participants (actual)
Sponsor and investigators
- Lead sponsor
- QIAGEN Gaithersburg, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Johnson, Principal investigator, QIAGEN Gaithersburg, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305534
- Sponsor's protocol ID
- SMF-18-0136-1-001
- Status last verified
- Sep 2025
- First submitted
- 22 Mar 2022
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: all samples are residual and anonymized
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05305534
- Acronym / sponsor ID
- SMF-18-0136-1-001
- Conditions
- Blood Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,142 participants (actual)
- Lead sponsor
- QIAGEN Gaithersburg, IncIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suspected of bloodstream infection
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QIAstat-Dx® BCID GN and GPF Plus AMR PanelsThe 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 | Device | – |
Primary outcome
PPA
Time frame: 6 moths
positive percentage agreement
NPA
Time frame: 6 moths
negative percentage agreement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No. all samples are residual and anonymized
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Johnson principal investigator
QIAGEN Gaithersburg, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Disease, run by QIAGEN Gaithersburg, Inc at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PPA (time frame: 6 moths). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.