QIAstat-Dx® Respiratory Panel Plus (RPP) Clinical Perform... | NCT05733559

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

NCT05733559

Sponsor

QIAGEN Gaithersburg, Inc

Status

Completed

Last Update Posted

Dec 5, 2023Actual

Enrollment

565Actual

Phase

Not provided

Conditions

Respiratory Disease

Interventions

QIAstat-Dx® Respiratory Panel Plus (RPP)

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 23, 2023Actual

Primary Completion Date

May 3, 2023Actual

Completion Date

Oct 11, 2023Actual

First Submitted Date

Feb 8, 2023

First Submission Date that Met QC Criteria

Feb 16, 2023

First Posted Date

Feb 17, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2023

Last Update Posted Date

Dec 5, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

565Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PPA	positive percentage agreement	8 weeks
NPA	negative percentage agreement	8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with symptoms of respiratory infection

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sarah Johnson	QIAGEN Gaithersburg, Inc	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
QIAGEN		Manchester			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012120	Respiration Disorders

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided