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

NCT05162547 | Completed

• 1 other identifier: SMF-21-2526-0-001
• Study Type: observational
• Target: 2,383
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Disease

Outcome Measures

Primary Outcomes (1)

• Positive Percentage Agreement

  positive percentage agreement

  6 months

Secondary Outcomes (1)

• Negative Percentage Agreement

  6 months

Interventions

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals presenting with influenza-like illness from all age groups

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• QIAGEN Gaithersburg, Inc: lead

Study Sites (1)

QIAGEN Gaithersburg, Inc

Manchester, M130BH, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

fresh and frozen leftover specimens from nasopharyngeal (NP) specimens collected from symptomatic individuals in transport medium.

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Sarah Johnson

  QIAGEN Gaithersburg, Inc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: December 17, 2021
• Study Start: March 11, 2022
• Primary Completion: February 7, 2024
• Study Completion: February 7, 2024
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)