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NCT05162547 Clinical Trial

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

Respiratory Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05162547
Other study ID # SMF-21-2526-0-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 11, 2022
Est. completion date February 28, 2024

Study information
Verified date December 2023
Source QIAGEN Gaithersburg, Inc
Contact Jennifer Ruth
Phone 7344770111
Email jennifer.ruth@qiagen.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1520
Est. completion date February 28, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• NeuMoDx™ FluA/FluB/RSV/SARS-CoV-2 Assay
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

Locations
Country Name City State
United Kingdom QIAGEN Gaithersburg, Inc Manchester

Sponsors (1)
Lead Sponsor Collaborator
QIAGEN Gaithersburg, Inc

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Positive Percentage Agreement positive percentage agreement 6 months
Secondary Negative Percentage Agreement negative percentage agreement 6 months
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