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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05162547

Enrollment

2383

Registered

2021-12-17

Start date

2022-03-11

Completion date

2024-02-07

Last updated

2025-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Disease

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.

Interventions

DEVICENeuMoDx™ 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

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Positive Percentage Agreement	6 months	positive percentage agreement

Secondary

Measure	Time frame	Description
Negative Percentage Agreement	6 months	negative percentage agreement

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026