Clinical Performance of QIAstat-Dx® Gastrointestinal Panel 2

NCT06745414 | Completed

• 1 other identifier: DHF-18-0129-0-CSP-001
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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

Conditions

Gastrointestinal Infection

Keywords

gastrointestinal infection; QIAstat-Dx; Clinical Performance Study

Outcome Measures

Primary Outcomes (2)

• Clinical sensitivity

  Positive percent agreement PPA

  8 months

• Clinical specificity

  Negative percent agreement NPA

  8 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with signs and symptoms of gastrointestinal infection

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• QIAGEN Gaithersburg, Inc: lead

Study Sites (1)

QIAGEN

Manchester, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fresh stool specimens in Cary-Blair transport media. Selected archived frozen stool specimens in Cary-Blair transport media will be tested retrospectively if required.

Study Officials

• Sarah Johnson

  Qiagen Manchester Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: September 14, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 17, 2025

Record last verified: 2024-01

Locations

GB (1)