Clinical Performance Evaluation of the NeuMoDx™ FluA/FluB/RSV/Severe Acute Respiratory Syndrome-CoV-2 Assay

Qiagen

Status: Completed

Conditions: Respiratory Disease

Treatments: Device: NeuMoDx™ FluA/FluB/RSV/SARS-CoV-2 Assay

Study type: Observational

Funder types: Industry

Identifiers

NCT05162547

SMF-21-2526-0-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,383 patients

Sex: All

Volunteers: No Healthy Volunteers

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.