NCT02067286

Detection of Influenza A, Influenza B, and RSV Using the Liat™ Assays on the Liat™ Analyzer

Multi-Center Study of In Vitro Diagnostic Devices for the Detection of Influenza A, Influenza B, and RSV

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,642 (actual)
• Sponsor: IQuum, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the clinical sensitivity and specificity of the Liat™ Influenza A/B \& RSV Assay and the Liat™ Influenza A/B Assay when used on the Liat Analyzer to detect the presence or absence of Influenza A, Influenza B, and RSV in a nasopharyngeal swab specimen as compared to an FDA approved NAAT and culture.

Conditions

• Influenza A
• Influenza B
• Respiratory Syncytial Virus (RSV)

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2014-02-20
• Last updated: 2016-08-31

Locations

8 sites across 1 country: United States