NCT00826709

Prospective Evaluation of the Fluid Rapid Influenza Test

CLINICAL STUDY PROTOCOL for the Prospective Evaluation of the fluID Rapid Influenza Test

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,300 (estimated)
• Sponsor: Nanogen, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the fluID Rapid Influenza Test's ability in detecting influenza A and influenza B from individuals presenting with signs and symptoms of influenza-like illness (ILI).

Detailed description

The primary objective of this study is to evaluate the clinical sensitivity and specificity of the fluID Rapid Influenza Test in detecting influenza A and influenza B, as evaluated with respect to fresh samples collected prospectively from individuals presenting with signs and symptoms of influenza-like illness (ILI). Test results will be compared with those obtained from viral culture testing of samples using the same specimen types, obtained from the same subjects. The specimen types under evaluation in this study will be nasal swab, nasopharyngeal swab, nasal wash and aspirate specimens. A secondary objective of this study is to evaluate the accuracy of the fluID Rapid Influenza Test in detecting each of the H1 and H3 subtypes of influenza A, in nasal swab, nasopharyngeal swab, nasal wash and aspirate specimens.

Conditions

• Influenza

Interventions

Type	Name	Description
DEVICE	fluID Rapid Influenza Test	The fluID™ Rapid Influenza Test is an in vitro diagnostic assay designed to be used with a reader for the qualitative detection of influenza type A and type B nucleoprotein antigens, and the differentiation of influenza type A subtypes A/H1 and A/H3 antigens associated with the seasonal influenza H1N1 and H3N2, in nasal swabs, nasopharyngeal swabs and nasal wash/aspirate specimens. The test is intended as an aid in the rapid, qualitative diagnosis of influenza type A and type B viral infections in patients symptomatic with influenza-like illness. The fluID™ Rapid Influenza Test is intended for use by a healthcare professional in a laboratory or Point-of-Care (POC).

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-10-01
• First posted: 2009-01-22
• Last updated: 2009-04-15

Locations

13 sites across 2 countries: United States, Hong Kong