Clinical Performance Evaluation of the NeuMoDx™ FluA/FluB/RSV/Severe Acute Respiratory Syndrome-CoV-2 Assay
Completed
- Conditions
- Respiratory Disease
- Registration Number
- NCT05162547
- Lead Sponsor
- QIAGEN Gaithersburg, Inc
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2383
Inclusion Criteria
- 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).
Exclusion Criteria
- Required information unable to be obtained from associated medical chart.
- Specimens not fitting criteria outlined above.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Positive Percentage Agreement 6 months positive percentage agreement
- Secondary Outcome Measures
Name Time Method Negative Percentage Agreement 6 months negative percentage agreement
Trial Locations
- Locations (1)
QIAGEN Gaithersburg, Inc
🇬🇧Manchester, United Kingdom