Clinical trial NCT06745414: Clinical Performance of QIAstat-Dx® Gastrointestinal Panel 2
Official title: An Observational, Prospective and Retrospective Clinical Study to Evaluate the Performance of QIAstat-Dx® Gastrointestinal Panel 2 During Normal Conditions of Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Infection
Keywords: gastrointestinal infection
QIAstat-Dx
Clinical Performance Study
Lead sponsor: QIAGEN Gaithersburg, Inc
Sponsor class: INDUSTRY
First posted: 2024-12-20
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with signs and symptoms of gastrointestinal infection

Brief 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

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

Eligibility criteria: Inclusion Criteria:

1. 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;
2. Stool specimen will be residual and obtained for completion of routine gastrointestinal testing;
3. Specimen for testing will consist of stool specimens preserved in Cary- Blair medium following the manufacturer's instructions for use;
4. Fresh, unpreserved stool must be transferred to Cary-Blair as soon as possible after specimen collection;
5. When fresh stool is transferred into the Cary-Blair container, the maximum fill line of the container should not be exceeded;
6. There is an adequate residual volume (minimum 1.0 mL) of Cary- Blair preserved stool specimens;
7. Cary- Blair preserved stool specimens should represent a homogenous suspension (easily vortexed);
8. 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);
9. Samples should be tested on the QIAstat-Dx® system and the reference method FilmArray within 3 hours of each other.

Exclusion Criteria:

1. Whole stool specimen that had been frozen;
2. Specimen that had been centrifuged;
3. Lack of clear subject identification or label on residual stool specimen;
4. Obvious physical damage of residual stool specimen;
5. Repeated specimens from the same subject;
6. Specimens in preservative collection media other than Cary-Blair;
7. Specimen containing formalin or any other fixative;
8. Rectal swab specimens
9. Specimens not collected according to manufacturer's instructions (under-filled or overfilled specimens);
10. Specimen contaminated with urine or water;
11. Leaking container.

Primary outcomes:
measure: Clinical sensitivity
timeFrame: 8 months
measure: Clinical specificity
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: QIAGEN
Study officials:
affiliation: Qiagen Manchester Limited
name: Sarah Johnson
role: PRINCIPAL_INVESTIGATOR
References: