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

Qiagen

Status: Completed

Conditions: Respiratory Disease

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

Study type: Observational

Funder types: Industry

Identifiers

NCT05733559

DHF-18-0127-0-CSP-003

Details and patient eligibility

About

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

Full 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

Enrollment: 565 patients

Sex: All

Volunteers: No Healthy Volunteers

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.