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

Completed

• Conditions: Respiratory Disease

• Registration Number: NCT05733559
• Lead Sponsor: QIAGEN Gaithersburg, Inc

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

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 Timeline

• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-16
• Study First Posted: 2023-02-17
• Study Start: 2023-02-23
• Primary Completion: 2023-05-03
• Status Verified: 2023-10
• Study Completion: 2023-10-11
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 565

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PPA	8 weeks	positive percentage agreement
NPA	8 weeks	negative percentage agreement

Trial Locations

Locations (1)

QIAGEN; 🇬🇧 Manchester, United Kingdom