Evaluation of iHealth COVID-19/Flu A&B Rapid Test for SARS-CoV-2 and Flu A&B Detection in Symptomatic Individuals
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.
• Written informed consent obtained prior to study enrollment.
• Male or female aged 2 years or older
• Subject is currently exhibiting two or more symptoms associated with COVID-19 or influenza (such as, but not limited to, fever, chills, cough, shortness of breath or difficulty breathing, fatigue, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting or diarrhea) (and must present within 6 days of symptom onset- For Antigen assay only). Subject must still be exhibiting symptoms on the day of sample collection.