Clinical Performance of QIAstat-Dx® Gastrointestinal Panel 2

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

• 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;
• 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.

Exclusion criteria

• 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;
• 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.