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

Sponsored by QIAGEN Gaithersburg, Inc

About this trial

Last updated 3 years ago

Study ID

SMF-21-2526-0-001

Status

Recruiting

Type

Observational

Placebo

No

Accepting

18-75 Years
All
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 3 years ago

What is this trial 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.

What are the participation requirements?

Yes

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).

No

Exclusion Criteria

- Required information unable to be obtained from associated medical chart.

- Specimens not fitting criteria outlined above.

Locations

Location

Status

Recruiting