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

Sponsor

QIAGEN Gaithersburg, Inc (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05162547

Collaborator

(none)

1,520

Enrollment

Location

4.7

Anticipated Duration (Months)

323.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Disease	Device: NeuMoDx™ FluA/FluB/RSV/SARS-CoV-2 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1520 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Multi-Center Clinical Performance Evaluation of the NeuMoDx™ FluA/FluB/RSV/Severe Acute Respiratory Syndrome-CoV-2 Assay on the NeuMoDx™ Molecular Systems

Actual Study Start Date :

Mar 11, 2022

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Outcome Measures

Primary Outcome Measures

Positive Percentage Agreement [6 months]
positive percentage agreement

Secondary Outcome Measures

Negative Percentage Agreement [6 months]
negative percentage agreement

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	QIAGEN Gaithersburg, Inc	Manchester		United Kingdom	M130BH

Sponsors and Collaborators

QIAGEN Gaithersburg, Inc

Investigators

Study Director: Sarah Johnson, QIAGEN Gaithersburg, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

QIAGEN Gaithersburg, Inc

ClinicalTrials.gov Identifier:

NCT05162547

Other Study ID Numbers:

SMF-21-2526-0-001

First Posted:

Dec 17, 2021

Last Update Posted:

Apr 4, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Severe Acute Respiratory Syndrome

Respiration Disorders

Respiratory Tract Diseases

Study Results

No Results Posted as of Apr 4, 2022