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The goal of this observational study is to evaluate the diagnostic performance of an investigational Flu A/B, COVID-19 and RSV test in patients with signs and symptoms of respiratory infection.
The main questions it aims to answer are:
Participants will:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Flu A/B Covid-19 and RSV Diagnostic Test | Diagnostic Test | A diagnostic test in lateral flow cassette format designed to detect Influenza A, Influenza B, SARS-CoV-2 and respiratory syncytial virus from anterior nasal swab specimens. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of the Investigational Test for Detection of Influenza A, Influenza B, SARS-CoV-2 and Respiratory Syncytial Virus Compared to an FDA-Cleared Reference Method | Within approximately 5 days of specimen collection (time needed for both investigational and comparator test results) |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals with flu-like symptoms presenting to participating clinical sites
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| iHealth Site 006 | Birmingham | Alabama | 35242 | United States | ||
| iHealth Site 021 |
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| Trussville |
| Alabama |
| 35173 |
| United States |
| iHealth Site 017 | Dublin | California | 94568 | United States |
| iHealth Site 007 | Huntington Park | California | 90255 | United States |
| iHealth Site 026 | Toluca Lake | California | 91602 | United States |
| iHealth Site 011 | DeLand | Florida | 32720 | United States |
| iHealth Site 013 | Doral | Florida | 33122 | United States |
| iHealth Site 004 | Fort Lauderdale | Florida | 33308 | United States |
| iHealth Site 005 | Fort Lauderdale | Florida | 33312 | United States |
| iHealth Site 019 | Palm Springs | Florida | 33461 | United States |
| iHealth Site 014 | Tamarac | Florida | 33321 | United States |
| iHealth Site 009 | Ammon | Idaho | 83406 | United States |
| iHealth Site 027 | Edison | New Jersey | 08820 | United States |
| iHealth Site 015 | Simpsonville | South Carolina | 29681 | United States |
| iHealth Site 016 | Spartanburg | South Carolina | 29301 | United States |
| iHealth Site 020 | Chattanooga | Tennessee | 37412 | United States |
| iHealth Site 003 | Brownsville | Texas | 78520 | United States |
| iHealth Site 002 | Edinburg | Texas | 78539 | United States |
| iHealth Site 018 | El Paso | Texas | 79902 | United States |
| iHealth Site 023 | Mesquite | Texas | 75149 | United States |
| iHealth Site 025 | Morgantown | West Virginia | 26505 | United States |
| iHealth Site 001 | Quebradillas | 00678 | Puerto Rico |
| iHealth Site 022 | San Juan | 000927 | Puerto Rico |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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