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NCT05733559 Clinical Trial

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

Respiratory Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05733559
Other study ID # DHF-18-0127-0-CSP-003
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 23, 2023
Est. completion date October 11, 2023

Study information
Verified date October 2023
Source QIAGEN Gaithersburg, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 565
Est. completion date October 11, 2023
Est. primary completion date May 3, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• QIAstat-Dx® Respiratory Panel Plus (RPP)
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

Locations
Country Name City State
United Kingdom QIAGEN Manchester

Sponsors (1)
Lead Sponsor Collaborator
QIAGEN Gaithersburg, Inc

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary PPA positive percentage agreement 8 weeks
Primary NPA negative percentage agreement 8 weeks
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