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Completed

NCT Number: NCT05733559

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

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

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Key information

Conditions

Respiratory Disease Respiration Disorders Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

QIAGEN

Manchester, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. PPA

    Time frame: 8 weeks

    positive percentage agreement

  2. NPA

    Time frame: 8 weeks

    negative percentage agreement

Sponsors and collaborators

Lead sponsor

QIAGEN Gaithersburg, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 17, 2023
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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