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

QIAGEN Gaithersburg, Inc565 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

565

Conditions

Respiratory Disease

Interventions

QIAstat-Dx® Respiratory Panel Plus (RPP)DEVICE

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

QIAGEN

Manchester, United Kingdom

Outcomes

Primary Outcomes

PPA

positive percentage agreement

Time frame: 8 weeks

NPA

negative percentage agreement

Time frame: 8 weeks

Data from ClinicalTrials.gov

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