SARS-CoV-2 Acute Respiratory DiseaseNCT06360757
Clinical Evaluation of the NeuMoDx SARS-CoV-2 Assay (COVID-19)
An observational study of SARS-CoV-2 Acute Respiratory Disease, run by QIAGEN Gaithersburg, Inc at 1 site in United Kingdom.
Trial summary
A multicenter study, using prospectively collected, fresh (Category I) and frozen (Category II), residual/leftover nasopharyngeal (NP) swab in UTM/UVT specimens obtained from symptomatic individuals suspected of COVID-19 infection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SARS-CoV-2 Acute Respiratory Disease
- What is being tested?
- NeuMoDx SARS-CoV-2 Assay
- How many people
- 503 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Feb 2024to 24 Jul 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: Symptomatic subjects suspected of COVID-19
Who may be able to join
- Any de-identified NP swab specimen in transport medium from a symptomatic individual suspected of COVID-19 at the time of collection.
- NP swab specimens obtained using a flexible mini-tip flocked swab and collected into 3mL Copan UTM [Cat. No. 305C] or BD UVT [Cat. No. 220531].
- Prospective specimens, fresh (Category I) shall be tested within:
- (4) hours when held at room temperature, or
- (3) days when held at (2 to 8°C), with cold storage starting within (4) hours of collection.
- Minimum volume of ≥ 2mL.
Who cannot join
- Required information unable to be obtained from the associated medical chart.
- Specimens that remained on-board the NeuMoDx System for > (8) hours prior to processing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-Center Clinical Performance Evaluation of the NeuMoDx SARS-CoV-2 Assay on the NeuMoDx Molecular Systems
A multicenter study, using prospectively collected, fresh (Category I) and frozen (Category II), residual/leftover nasopharyngeal (NP) swab in UTM/UVT specimens obtained from symptomatic individuals suspected of COVID-19 infection. This study will evaluate the NeuMoDx SARS-CoV-2 Assay's clinical performance on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems.
- Conditions
- SARS-CoV-2 Acute Respiratory Disease
- Being tested
- NeuMoDx SARS-CoV-2 Assay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuMoDx SARS-CoV-2 AssayDiagnostic test
The NeuMoDx™ SARS-CoV-2 Assay is an automated, in vitro nucleic acid amplification test intended for the qualitative detection of SARS-CoV-2 RNA in nasopharyngeal (NP) swabs in transport medium obtained from symptomatic individuals suspected of COVID-19 infection. The NeuMoDx SARS-CoV-2 Assay as performed on the NeuMoDx™ 288 Molecular System and NeuMoDx™ 96 Molecular System incorporates automated RNA extraction to isolate target nucleic acids from the specimen and real-time reverse transcription PCR targeting two conserved regions of the SARS-CoV-2 genome.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity as compared to the comparator method
Sensitivity ≥ 95% with a lower bound of the two-sided 95% CI > 90%
Measured: Through study completion estimated 9 months
Secondary outcomes (1)
Specificity
Specificity ≥ 95% with a lower bound of the two-sided 95% CI > 90%
Measured: Through study completion estimated 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start6 Feb 2024
- Primary completion24 Jul 2024
- Study completion24 Jul 2024
Why it stopped: Discontinuation of product line
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 Acute 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
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- QIAGEN Gaithersburg, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360757
- Sponsor's protocol ID
- DHF-21-2141-1
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 SARS-CoV-2 Assay on the NeuMoDx Molecular Systems
- ClinicalTrials.gov ID
- NCT06360757
- Acronym / sponsor ID
- DHF-21-2141-1
- Conditions
- SARS-CoV-2 Acute Respiratory Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Discontinuation of product line
- Enrolment
- 503 participants (actual)
- Lead sponsor
- QIAGEN Gaithersburg, IncIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 11 Apr 2024 (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.
A multicenter study, using prospectively collected, fresh (Category I) and frozen (Category II), residual/leftover nasopharyngeal (NP) swab in UTM/UVT specimens obtained from symptomatic individuals suspected of COVID-19 infection. This study will evaluate the NeuMoDx SARS-CoV-2 Assay's clinical performance on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems.
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
- Symptomatic subjects suspected of COVID-19
Key inclusion criteria (6 listed)
- Any de-identified NP swab specimen in transport medium from a symptomatic individual suspected of COVID-19 at the time of collection.
- NP swab specimens obtained using a flexible mini-tip flocked swab and collected into 3mL Copan UTM [Cat. No. 305C] or BD UVT [Cat. No. 220531].
- Prospective specimens, fresh (Category I) shall be tested within:
- Minimum volume of ≥ 2mL.
Key exclusion criteria (2 listed)
- Required information unable to be obtained from the associated medical chart.
- Specimens that remained on-board the NeuMoDx System for > (8) hours prior to processing.
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 SARS-CoV-2 AssayThe NeuMoDx™ SARS-CoV-2 Assay is an automated, in vitro nucleic acid amplification test intended for the qualitative detection of SARS-CoV-2 RNA in nasopharyngeal (NP) swabs in transport medium obtained from symptomatic individuals suspected of COVID-19 infection. The NeuMoDx SARS-CoV-2 Assay as performed on the NeuMoDx™ 288 Molecular System and NeuMoDx™ 96 Molecular System incorporates automated RNA extraction to isolate target nucleic acids from the specimen and real-time reverse transcription PCR targeting two conserved regions of the SARS-CoV-2 genome. | Diagnostic test | – |
Primary outcome
Sensitivity as compared to the comparator method
Time frame: Through study completion estimated 9 months
Sensitivity ≥ 95% with a lower bound of the two-sided 95% CI > 90%
1 secondary outcome
Specificity
Time frame: Through study completion estimated 9 months
Results and safety
The study was stopped early (reason given: Discontinuation of product line). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 SARS-CoV-2 Acute 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: stopped early, 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 was stopped early (reason given: Discontinuation of product line). Results are not available in the source record.
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?
Sensitivity as compared to the comparator method (time frame: Through study completion estimated 9 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.