Gastrointestinal InfectionNCT06745414
Clinical Performance of QIAstat-Dx® Gastrointestinal Panel 2
An observational study of Gastrointestinal Infection, run by QIAGEN Gaithersburg, Inc at 1 site in United Kingdom.
Trial summary
Performance evaluation of QIAstat-Dx® GI2 Panel using the QIAstat-Dx® Analyzer to demonstrate that the QIAstat-Dx® GI2 Panel achieves its intended performance during normal conditions of use by the intended user in the intended environment Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastrointestinal Infection
- How many people
- 2,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Sep 2020to 31 Dec 2021
- 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 with signs and symptoms of gastrointestinal infection
Who may be able to join
- Stool specimen must have been collected from subjects/patients which meet the institute's criteria for a suspected enteric pathogen, such as individuals presenting with symptoms of gastrointestinal infection;
- Stool specimen will be residual and obtained for completion of routine gastrointestinal testing;
- Specimen for testing will consist of stool specimens preserved in Cary- Blair medium following the manufacturer's instructions for use;
- Fresh, unpreserved stool must be transferred to Cary-Blair as soon as possible after specimen collection;
- When fresh stool is transferred into the Cary-Blair container, the maximum fill line of the container should not be exceeded;
- There is an adequate residual volume (minimum 1.0 mL) of Cary- Blair preserved stool specimens;
Show all 11Show fewer
- Cary- Blair preserved stool specimens should represent a homogenous suspension (easily vortexed);
- Cary- Blair preserved stool specimens have been stored at the following conditions prior testing:
- Up to 4 days at Room Temperature (15 to 25˚C).
- Up to 4 days at 2 to 8˚C (refrigerated);
- Samples should be tested on the QIAstat-Dx® system and the reference method FilmArray within 3 hours of each other.
Who cannot join
- Whole stool specimen that had been frozen;
- Specimen that had been centrifuged;
- Lack of clear subject identification or label on residual stool specimen;
- Obvious physical damage of residual stool specimen;
- Repeated specimens from the same subject;
- Specimens in preservative collection media other than Cary-Blair;
Show all 11Show fewer
- Specimen containing formalin or any other fixative;
- Rectal swab specimens
- Specimens not collected according to manufacturer's instructions (under-filled or overfilled specimens);
- Specimen contaminated with urine or water;
- Leaking container.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational, Prospective and Retrospective Clinical Study to Evaluate the Performance of QIAstat-Dx® Gastrointestinal Panel 2 During Normal Conditions of Use
Performance evaluation of QIAstat-Dx® GI2 Panel using the QIAstat-Dx® Analyzer to demonstrate that the QIAstat-Dx® GI2 Panel achieves its intended performance during normal conditions of use by the intended user in the intended environment
Read the detailed description
The objective of the study is to demonstrate that the QIAstat-Dx® Gastrointestinal Panel 2 achieves its intended performance during normal conditions of use by the intended user in the intended environment.
The primary objective is to evaluate the performance of QIAstat-Dx® GI2 Panel in comparison with the results obtained from the reference methods.
The secondary objective of the study is to evaluate the safety of QIAstat-Dx® GI2 Panel with respect to users/operators.
The primary study endpoint will be the results for each analyte obtained from testing prospective and retrospective specimens with QIAstat-Dx® GI2 Panel and Reference Method(s). Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) will be determined
- Conditions
- Gastrointestinal Infection
- Keywords
- gastrointestinal infection, QIAstat-Dx, Clinical Performance Study
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical sensitivity
Positive percent agreement PPA
Measured: 8 months
Clinical specificity
Negative percent agreement NPA
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start14 Sep 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal InfectionStudies 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
- 2,000 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 Manchester Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745414
- Sponsor's protocol ID
- DHF-18-0129-0-CSP-001
- Status last verified
- Jan 2024
- First submitted
- 17 Dec 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Prospective and Retrospective Clinical Study to Evaluate the Performance of QIAstat-Dx® Gastrointestinal Panel 2 During Normal Conditions of Use
- ClinicalTrials.gov ID
- NCT06745414
- Acronym / sponsor ID
- DHF-18-0129-0-CSP-001
- Conditions
- Gastrointestinal Infection
- Keywords
- gastrointestinal infection, QIAstat-Dx, Clinical Performance Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- QIAGEN Gaithersburg, IncIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 20 Dec 2024 (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.
Performance evaluation of QIAstat-Dx® GI2 Panel using the QIAstat-Dx® Analyzer to demonstrate that the QIAstat-Dx® GI2 Panel achieves its intended performance during normal conditions of use by the intended user in the intended environment
Detailed description
The objective of the study is to demonstrate that the QIAstat-Dx® Gastrointestinal Panel 2 achieves its intended performance during normal conditions of use by the intended user in the intended environment.
The primary objective is to evaluate the performance of QIAstat-Dx® GI2 Panel in comparison with the results obtained from the reference methods.
The secondary objective of the study is to evaluate the safety of QIAstat-Dx® GI2 Panel with respect to users/operators.
The primary study endpoint will be the results for each analyte obtained from testing prospective and retrospective specimens with QIAstat-Dx® GI2 Panel and Reference Method(s). Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) will be determined
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 with signs and symptoms of gastrointestinal infection
Key inclusion criteria (11 listed)
- Stool specimen must have been collected from subjects/patients which meet the institute's criteria for a suspected enteric pathogen, such as individuals presenting with symptoms of gastrointestinal infection;
- Stool specimen will be residual and obtained for completion of routine gastrointestinal testing;
- Specimen for testing will consist of stool specimens preserved in Cary- Blair medium following the manufacturer's instructions for use;
- Fresh, unpreserved stool must be transferred to Cary-Blair as soon as possible after specimen collection;
- When fresh stool is transferred into the Cary-Blair container, the maximum fill line of the container should not be exceeded;
Key exclusion criteria (11 listed)
- Whole stool specimen that had been frozen;
- Specimen that had been centrifuged;
- Lack of clear subject identification or label on residual stool specimen;
- Obvious physical damage of residual stool specimen;
- Repeated specimens from the same subject;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical sensitivity
Time frame: 8 months
Positive percent agreement PPA
Clinical specificity
Time frame: 8 months
Negative percent agreement NPA
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 17 Jan 2025.
Related trials for Gastrointestinal Infection
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
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 Manchester Limited
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 Gastrointestinal Infection, 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 11 inclusion and 11 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 17 Jan 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?
Clinical sensitivity (time frame: 8 months). 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 17 Jan 2025.