Clinical Performance of QIAstat-Dx® Gastrointestinal Panel 2

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

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

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.