Influenza Diagnosis, Treatment and Surveillance With Xpert Flu

Four strategically selected medical centers across the US (representing the West Coast,
Southwest, Midwest; and East Coast) will enroll adult subjects presenting to the ED with an
acute respiratory illness who fulfill CDC recommended criteria for receiving antiviral
therapy. At each of the 4 sites, dedicated research coordinators will approach all adult
(age > 18 years old) ED patients with broadly defined respiratory related complaints and
screen for those who meet CDC recommended criteria for antiviral therapy (i.e. those at
'high-risk for complications' or those with 'potential influenza-related complications).

Consenting subjects will have a nasopharyngeal (NP) swab collected for both Xpert Flu
testing and gold standard reverse transcription-PCR (rt-PCR) testing under a research
protocol. The investigators will compare the test results from the rapid flu testing to that
of the gold standard rt-PCR testing in order to assess the clinical performance
characteristics of the new rapid test (Objective 1). The investigators will also collect
demographics and medical historical information using a brief structured data form, which
will be used in combination with rt-PCR test results to derive and validate a clinical
decision guideline (Objective 2).

The investigators will simultaneously randomize 2 of the 4 hospitals to the Rapid Testing
Group (which will have systematic rapid flu testing performed with results provided to the
clinicians), or the Control Group (which will follow standard of care practice with testing
left to the discretion of individual clinicians). This will permit comparison of rates of ED
antiviral administration or prescription between the two groups to assess the clinical
impact of influenza testing (Objective 3). Finally, cost data from the ED visits and
subsequent hospitalization will be collected from subjects in both the rapid testing group
and the control group to inform a cost-utility analysis of rapid influenza testing compared
to current standard of care (Objective 4).

Inclusion Criteria:

- 18 years old or older

- Acute respiratory tract infection, i.e. in the past two days the subject has
experienced any of the following symptoms: new or increased cough, new or increased
shortness of breath, change in sputum production (for adults 65 years or older), new
sinus pain, new nasal congestion/rhinorrhea, new sore throat, new fever, triage
temperature greater than or equal to 38F

- CDC Criteria for influenza antiviral treatment, i.e. is the subject at risk for
influenza complications or does the subject have potential current influenza
complications including: 65 years old or older, pregnant (or less than 2 weeks
post-partum), American Indian or Alaska Native, morbid obesity (BMI greater than 40),
current resident of a chronic care facility, chronic pulmonary disease,
cardiovascular disease (except isolated hypertension), renal disease, hepatic
disease, hematologic disease, metabolic disease, neurologic disease, immunosupression
due to [HIV or AIDS, transplant, chemotherapy, medications, other - specify]. OR does
the subject have potential current influenza complications such as: admitted to the
hospital or a diagnosis of pneumonia.

Exclusion Criteria:

- Unable to speak or understand English or Spanish

- Unable to provide consent

- Lack of follow up information (i.e. working telephone number)

- Have an influenza diagnosis in the past 2 weeks (i.e. either given antivirals or had
a confirmatory influenza test)

- Previously enrolled in this study