Trials / Terminated
TerminatedNCT06360757
Clinical Evaluation of the NeuMoDx SARS-CoV-2 Assay (COVID-19)
Multi-Center Clinical Performance Evaluation of the NeuMoDx SARS-CoV-2 Assay on the NeuMoDx Molecular Systems
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 503 (actual)
- Sponsor
- QIAGEN Gaithersburg, Inc · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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. This study will evaluate the NeuMoDx SARS-CoV-2 Assay's clinical performance on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | NeuMoDx SARS-CoV-2 Assay | 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. |
Timeline
- Start date
- 2024-02-06
- Primary completion
- 2024-07-24
- Completion
- 2024-07-24
- First posted
- 2024-04-11
- Last updated
- 2025-03-18
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT06360757. Inclusion in this directory is not an endorsement.