NCT05733559

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 565 (actual)
• Sponsor: QIAGEN Gaithersburg, Inc · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Respiratory Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-02-23
• Primary completion: 2023-05-03
• Completion: 2023-10-11
• First posted: 2023-02-17
• Last updated: 2023-12-05

Locations

1 site across 1 country: United Kingdom