Clinical Evaluation of the NeuMoDx SARS-CoV-2 Assay (COVID-19)
NCT ID: NCT06360757
Last Updated: 2025-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
503 participants
OBSERVATIONAL
2024-02-06
2024-07-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. NP swab specimens obtained using a flexible mini-tip flocked swab and collected into 3mL Copan UTM \[Cat. No. 305C\] or BD UVT \[Cat. No. 220531\].
3. Prospective specimens, fresh (Category I) shall be tested within:
1. (4) hours when held at room temperature, or
2. (3) days when held at (2 to 8°C), with cold storage starting within (4) hours of collection.
4. Minimum volume of ≥ 2mL.
Exclusion Criteria
2. Specimens that remained on-board the NeuMoDx System for \> (8) hours prior to processing.
ALL
No
Sponsors
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QIAGEN Gaithersburg, Inc
INDUSTRY
Responsible Party
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Locations
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QIAGEN Gaithersburg, Inc
Manchester, , United Kingdom
Countries
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Other Identifiers
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DHF-21-2141-1
Identifier Type: -
Identifier Source: org_study_id
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