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OpenTrials
Completed

NCT Number: NCT05162547

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

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.

Completed

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Key information

Conditions

Respiratory Disease Respiration Disorders Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

QIAGEN Gaithersburg, Inc

Manchester, M130BH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Positive Percentage Agreement

    Time frame: 6 months

    positive percentage agreement

Secondary outcomes

  1. Negative Percentage Agreement

    Time frame: 6 months

    negative percentage agreement

Sponsors and collaborators

Lead sponsor

QIAGEN Gaithersburg, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 17, 2021
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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