Prospective Evaluation of the Fluid Rapid Influenza Test
Prospective Evaluation of the Fluid Rapid Influenza Test
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).
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.
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. 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 swab samples, nasal wash or
 aspirate samples is contraindicated or not possible.

 4. Subjects with a medical condition that prevents swab samples or 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.