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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

565 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-23

Study Completion Date

2023-10-11

Brief Summary

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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

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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

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Respiratory Disease

Keywords

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Respiratory Virus SARS-CoV-2 coronavirus

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Johnson

Role: STUDY_DIRECTOR

QIAGEN Gaithersburg, Inc

Locations

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QIAGEN

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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DHF-18-0127-0-CSP-003

Identifier Type: -

Identifier Source: org_study_id