Evaluation of COVID-19 and Flu A/B 3 in 1 Combo Rapid Test

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Subject who is 18 years of age (or the state's legal age of majority) or older and does not understand or is not able and willing to sign the study informed consent.
• Subject has had seasonal influenza and/or the SARS-CoV-2 vaccine within the past 5 days.
• Subject is not able to tolerate sample collection, or is not willing to contribute the required swab samples for testing or complete the study procedures.
• Subject is currently undergoing antiviral treatment such as baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir (Rapivab®).
• Subjects currently undergoing treatment and/or within the past thirty (30) days with prescription medication to treat novel Coronavirus SARS-CoV-2 infection, which may include but is not limited to Remdesivir (Veklury), Paxlovid, molnupiravir or receiving convalescent plasma therapy for SARS-CoV-2.
• Subjects who have taken Evusheld (tixagevimab/cilgavimab) within the last 90 days
• Subjects who have had a nasal wash or aspirate as part of their standard of care treatment on day of study visit prior to the study sample collection.
• Subjects who have had recent craniofacial injury or surgery, including to correct deviation of the nasal septum, within the previous six (6) months