Clinical Performance of QIAstat-Dx® Gastrointestinal Panel 2

January 15, 2025 updated by: QIAGEN Gaithersburg, Inc

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

Study Overview

Status

Completed

Conditions

Gastrointestinal Infection

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 Type

Observational

Enrollment (Actual)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- - Manchester, United Kingdom
    - QIAGEN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Patients with signs and symptoms of gastrointestinal infection

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical sensitivity Time Frame: 8 months	Positive percent agreement PPA	8 months
Clinical specificity Time Frame: 8 months	Negative percent agreement NPA	8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

QIAGEN Gaithersburg, Inc

Investigators

Principal Investigator: Sarah Johnson, Qiagen Manchester Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2020

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria