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

QIAGEN Gaithersburg, Inc1 site in 1 country2,383 target enrollmentMarch 11, 2022

ConditionsRespiratory Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Respiratory Disease
Sponsor: QIAGEN Gaithersburg, Inc
Enrollment: 2383
Locations: 1
Primary Endpoint: Positive Percentage Agreement
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 11, 2022

End Date

February 7, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

QIAGEN Gaithersburg, Inc

Responsible Party

Sponsor

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).