Clinical Performance Evaluation of the NeuMoDx™ FluA/FluB... | NCT05162547

Studies
Clinical Performance Evaluation of the NeuMoDx™ FluA/FluB/RSV/Severe Acute Respiratory Syndrome-CoV-2 Assay

NCT05162547

Sponsor

QIAGEN Gaithersburg, Inc

Status

Completed

Last Update Posted

Mar 18, 2025Actual

Enrollment

2,383Actual

Phase

Not provided

Conditions

Respiratory Disease

Interventions

NeuMoDx™ FluA/FluB/RSV/SARS-CoV-2 Assay

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

Mar 2025

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

Mar 11, 2022Actual

Primary Completion Date

Feb 7, 2024Actual

Completion Date

Feb 7, 2024Actual

First Submitted Date

Dec 9, 2021

First Submission Date that Met QC Criteria

Dec 9, 2021

First Posted Date

Dec 17, 2021Actual

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

Mar 14, 2025

Last Update Posted Date

Mar 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To demonstrate the clinical performance of the NeuMoDx™ FluA/FluB/RSV/SARS-CoV-2 Assay on the NeuMoDx Systems by determining clinical sensitivity and specificity of the Assay.

Detailed Description

To evaluate the clinical performance of the NeuMoDx™ FluA/FluB/RSV/SARS-CoV-2 Assay on the on the NeuMoDx™ 288 and 96 Molecular Systems, collectively referred to as NeuMoDx Systems. The results of this study will be used to support regulatory registration and product release in the US, Europe and other markets.

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

2,383Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NeuMoDx™ FluA/FluB/RSV/SARS-CoV-2 Assay	Device	The NeuMoDx™ FluA/FluB/RSV/SARS-CoV-2 Assay (IUO) is a multiplexed, in vitro real-time Polymerase Chain Reaction assay, diagnostic test intended for the simultaneous qualitative detection and differentiation of Influenza A virus (Flu A), Influenza B virus (Flu B), Respiratory Syncytial Virus (RSV) and SARS-CoV-2 RNA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Positive Percentage Agreement	positive percentage agreement	6 months

Secondary Outcomes

Measure	Description	Time Frame
Negative Percentage Agreement	negative percentage agreement	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fresh specimens shall be collected from all comers across the study duration
Collected from individuals of any age presenting with influenza-like illness (ILI)
Nasopharyngeal (NP) swab specimen obtained using a flexible mini-tip flocked swab and collected into 3 mL Copan® Universal Transport Media (UTM) [Cat. No.305c] or Beckton Dickinson (BD™) Universal Viral Transport (UVT) [Cat. No. 220531]
Minimum volume for residual specimen approximately 2 mL
Fresh specimens to be tested within 3 days of collection.
Fresh specimens to be stored under the recommended stability conditions (2-8°C).

Exclusion Criteria:

Required information unable to be obtained from associated medical chart.
Specimens not fitting criteria outlined above.

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

Individuals presenting with influenza-like illness from all age groups

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 Gaithersburg, Inc		Manchester		M130BH	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

all samples are residual and anonymized

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided