NCT05733559

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
565

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

February 23, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2023

Completed
Last Updated

December 5, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

February 8, 2023

Last Update Submit

December 1, 2023

Conditions

Respiratory Disease

Keywords

Respiratory VirusSARS-CoV-2 coronavirus

Outcome Measures

Primary Outcomes (2)

  • PPA

    positive percentage agreement

    8 weeks

  • NPA

    negative percentage agreement

    8 weeks

Interventions

QIAstat-Dx® Respiratory Panel Plus (RPP)DEVICE

An observational prospective performance evaluation study of QIAstat-Dx® Respiratory Panel Plus (RPP) SARS-CoV-2 target against a marketed comparator, using NPS collected per the manufacturer's instructions and eluted in Universal Transport Media (UTM) from subjects with signs and symptoms of respiratory infection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with symptoms of respiratory infection

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QIAGEN

Manchester, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal Swab (NPS) collected per the manufacturer's instructions and eluted in Universal Transport Media (UTM) from subjects with signs and symptoms of respiratory infection

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Sarah Johnson

    QIAGEN Gaithersburg, Inc

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 8, 2023

First Posted

February 17, 2023

Study Start

February 23, 2023

Primary Completion

May 3, 2023

Study Completion

October 11, 2023

Last Updated

December 5, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)