Respiratory Disease
Conditions
Keywords
Respiratory Virus, SARS-CoV-2 coronavirus
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
Interventions
DEVICEQIAstat-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
Sponsors
QIAGEN Gaithersburg, Inc
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PPA | 8 weeks | positive percentage agreement |
| NPA | 8 weeks | negative percentage agreement |
Countries
United Kingdom
Outcome results
None listed