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

NCT05162547 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2383

Last updated 2025-03-18

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • QIAGEN Gaithersburg, Inc

    lead INDUSTRY

Principal Investigators

  • Sarah Johnson · QIAGEN Gaithersburg, Inc

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-11
Primary Completion
2024-02-07
Completion
2024-02-07

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05162547 on ClinicalTrials.gov