Respiratory DiseaseNCT05162547
Clinical Performance Evaluation of the NeuMoDx™ FluA/FluB/RSV/Severe Acute Respiratory Syndrome-CoV-2 Assay
An observational study of Respiratory Disease, run by QIAGEN Gaithersburg, Inc at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Disease
- What is being tested?
- NeuMoDx™ FluA/FluB/RSV/SARS-CoV-2 Assay
- Type of treatment
- Medical device
- How many people
- 2,383 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Mar 2022to 7 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals presenting with influenza-like illness from all age groups
Who may be able to join
- 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).
Who cannot join
- Required information unable to be obtained from associated medical chart.
- Specimens not fitting criteria outlined above.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Respiratory Disease
- Being tested
- NeuMoDx™ FluA/FluB/RSV/SARS-CoV-2 Assay
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuMoDx™ FluA/FluB/RSV/SARS-CoV-2 AssayDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Percentage Agreement
positive percentage agreement
Measured: 6 months
Secondary outcomes (1)
Negative Percentage Agreement
negative percentage agreement
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start11 Mar 2022
- Primary completion7 Feb 2024
- Study completion7 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,383 participants (actual)
Sponsor and investigators
- Lead sponsor
- QIAGEN Gaithersburg, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Johnson, Study director, QIAGEN Gaithersburg, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162547
- Sponsor's protocol ID
- SMF-21-2526-0-001
- Status last verified
- Mar 2025
- First submitted
- 9 Dec 2021
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: all samples are residual and anonymized
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05162547
- Acronym / sponsor ID
- SMF-21-2526-0-001
- Conditions
- Respiratory Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,383 participants (actual)
- Lead sponsor
- QIAGEN Gaithersburg, IncIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 7 Feb 2024 (actual)
- Study completion
- 7 Feb 2024 (actual)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals presenting with influenza-like illness from all age groups
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Required information unable to be obtained from associated medical chart.
- Specimens not fitting criteria outlined above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuMoDx™ FluA/FluB/RSV/SARS-CoV-2 AssayThe 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 | Device | – |
Primary outcome
Positive Percentage Agreement
Time frame: 6 months
positive percentage agreement
1 secondary outcome
Negative Percentage Agreement
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: No. all samples are residual and anonymized
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Johnson study director
QIAGEN Gaithersburg, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Disease, run by QIAGEN Gaithersburg, Inc at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Percentage Agreement (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.