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QIAstat-Dx® Respiratory Panel Plus (RPP) Clinical Performance Study

Sponsor
QIAGEN Gaithersburg, Inc (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05733559
Collaborator
(none)
500
Enrollment
2.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study will evaluate the clinical performance of the QIAstat-Dx® Respiratory Panel Plus (RPP) SARS-CoV-2 target with a validated comparator method

Condition or Disease Intervention/Treatment Phase
  • Device: QIAstat-Dx® Respiratory Panel Plus (RPP)

Detailed Description

This multicentre study aims to evaluation the clinical performance of the QIAstat-Dx® Respiratory Panel Plus (RPP) SARS-CoV-2 target with a validated comparator method

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
An Observational Prospective Clinical Study to Assess Clinical Performance of QIAstat-Dx® Respiratory Panel Plus (RPP) SARS-CoV-2 Target in the Intended Use Population and Environment
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Outcome Measures

Primary Outcome Measures

  1. PPA [8 weeks]

    positive percentage agreement

  2. NPA [8 weeks]

    negative percentage agreement

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Presenting with signs and symptoms of a respiratory infection.

Consent or assent to be obtained

Able to communicate (speak, read and write) in local language, and able to understand and sign the required study documents.

Willing and able to provide Nasopharyngeal Swab (NPS) Specimen collected per manufacturer's instructions.

Exclusion Criteria:

Subjects who, in the opinion of the Investigator, are unsuitable for participation in the study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • QIAGEN Gaithersburg, Inc

Investigators

  • Study Director: Sarah Johnson, QIAGEN Gaithersburg, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
QIAGEN Gaithersburg, Inc
ClinicalTrials.gov Identifier:
NCT05733559
Other Study ID Numbers:
  • DHF-18-0127-0-CSP-003
First Posted:
Feb 17, 2023
Last Update Posted:
Feb 17, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by QIAGEN Gaithersburg, Inc
Respiratory Virus
SARS-CoV-2 coronavirus
Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases

Study Results

No Results Posted as of Feb 17, 2023