Influenza Clinical Trial
Official title:
Comparison of fluID Rapid Influenza and BinaxNOW® Influenza A & B
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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