This observational study aims to evaluate the diagnostic performance of an investigational Influenza A/B and COVID-19 test in patients presenting with signs and symptoms of respiratory infection. The main questions it aims to answer are: 1. What is the sensitivity and specificity of the investigational test compared with an FDA-cleared reference method for detection of Influenza A, Influenza B, and SARS-CoV-2 antigen. 2. What is the overall positive and negative percent agreement between the investigational test and the reference method? Participants will: 1. Provide a respiratory specimen (e.g., nasal or nasopharyngeal swab) for testing with the investigational device. 2. Provide an additional specimen for testing with the FDA-cleared reference method.
Study Type
OBSERVATIONAL
Enrollment
588
A diagnostic test in lateral flow cassette format designed to detect Influenza A, Influenza B and SARS-CoV-2 from anterior nasal swab specimens.
iHealth Site 006
Birmingham, Alabama, United States
iHealth Site 021
Trussville, Alabama, United States
iHealth Site 017
Dublin, California, United States
iHealth Site 007
Huntington Park, California, United States
iHealth Site 008
Los Angeles, California, United States
iHealth Site 013
Doral, Florida, United States
iHealth Site 004
Fort Lauderdale, Florida, United States
iHealth Site 005
Fort Lauderdale, Florida, United States
iHealth Site 014
Tamarac, Florida, United States
iHealth Site 009
Ammon, Idaho, United States
...and 5 more locations
Sensitivity and Specificity of the Investigational Test for Detection of Influenza A, Influenza B and SARS-CoV-2 Compared to an FDA-Cleared Reference Method
Time frame: Within approximately 5 days of specimen collection (time needed for both investigational and comparator test results)
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