NCT00828100

Comparison of Fluid Rapid Influenza and BinaxNOW Influenza A & B

Comparison of fluID Rapid Influenza and BinaxNOW® Influenza A & B

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 650 (estimated)
• Sponsor: Nanogen, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to compare the performance of the investigational fluid Rapid Influenza Test and the BinaxNOW® Influenza A \& B Test in detecting influenza type A and influenza type B.

Detailed description

The primary objective of this study is to compare the performance of the investigational fluID Rapid Influenza Test and the BinaxNOW® Influenza A \& B Test in detecting influenza type A and influenza type B, with respect to fresh nasal wash / aspirate specimens collected from patients presenting with signs and symptoms of influenza-like illness (ILI). Specimens to be evaluated in this study will be enrolled in a concurrent clinical study per protocol FLU-05, entitled "Prospective Evaluation of the fluID Rapid Influenza Test". All subjects enrolled in the FLU-05 study will have consented to having their samples used in future investigations involving the fluID Test. This study will be conducted during the 2008-2009 influenza season in North America and Hong Kong, which is anticipated to run from November 2008 to May 2009. Should the influenza season conclude in North America and Hong Kong prior to the attainment of the minimum target enrollment specified in the FLU-05 study, study sites in Australia will also be enlisted in order to enroll subjects; in such a case, enrollment will continue during the 2009 influenza season in these countries, which is anticipated to run from May through October, 2009.

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) setting.
DEVICE	BinaxNOW® Influenza A & B	The BinaxNOW Influenza A \& B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal wash/aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results should be confirmed by culture.

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-05-01
• First posted: 2009-01-23
• Last updated: 2009-03-06

Locations

2 sites across 1 country: United States