Comparison of Fluid Rapid Influenza and BinaxNOW Influenza A & B
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.
Inclusion Criteria:

 1. Male or female subjects of any age;

 2. Subjects presenting to the investigative site within 4 days of symptom onset, with:

 -  Fever ≥ 38.0°C (100.4°F) if taken orally, or ≥ 38.5°C (101.2°F) if taken
 rectally; or a self-reported history of fever or feeling feverish (includes fever
 controlled by medication) in the absence of documented fever;

 -  One or more respiratory symptoms of influenza-like illness which may include the
 following:

 -  Sore throat

 -  Runny or stuffy nose

 -  Cough

 -  One or more constitutional symptoms of influenza-like illness which may include
 the following:

 -  Myalgia (aches and pains)

 -  Headache

 -  Fatigue

 3. Subjects (or parent/guardian) willing and able to provide informed consent;

 4. Subjects must be enrolled in Arm 3 of the FLU-05 clinical study.

 Written subject informed consent for this study protocol must be obtained prior to study
 enrollment. Each subject (or parent or guardian) must personally sign and date the Subject
 Informed Consent Form prior to his/her participation in this clinical study.

 Exclusion Criteria:

 1. Subjects not presenting with at least three symptoms of influenza-like illness as
 outlined above.

 2. Subjects who have received influenza antiviral medication or an investigational
 influenza drug treatment within the previous 30 days of study enrollment.

 3. Subjects (children and adults) for whom the obtaining of aspirate samples is
 contraindicated or not possible.

 4. Subjects with a medical condition that prevents nasal washes or aspirate samples from
 being obtained.

 5. Active duty military personnel (participating military study sites only).

 6. Subjects (or parent/guardian) unwilling or unable to provide informed consent.