Clinical Performance Evaluation of the NeuMoDx™ FluA/FluB/RSV/Severe Acute Respiratory Syndrome-CoV-2 Assay
NCT ID: NCT05162547
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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COMPLETED
2383 participants
OBSERVATIONAL
2022-03-11
2024-02-07
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™ 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
Eligibility Criteria
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Inclusion Criteria
* 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
* Specimens not fitting criteria outlined above.
ALL
No
Sponsors
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QIAGEN Gaithersburg, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Sarah Johnson
Role: STUDY_DIRECTOR
QIAGEN Gaithersburg, Inc
Locations
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QIAGEN Gaithersburg, Inc
Manchester, , United Kingdom
Countries
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Other Identifiers
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SMF-21-2526-0-001
Identifier Type: -
Identifier Source: org_study_id
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