1. Written informed consent obtained prior to study enrollment.
2. Male or female aged 6 months of age and older.
3. Participant, aged 2 years and older, is currently exhibiting at least one or more symptoms (i.e. symptomatic) associated with COVID-19, influenza and RSV (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 (equates to 5 DPSO). Subject must still be exhibiting symptom(s) on the day of sample collection.
or Participant, aged 6 to \<24 months, is currently exhibiting one or more symptoms (i.e. symptomatic) associated with COVID-19, influenza or RSV (such as, but not limited to, fever, cough, short and shallow breathing, unusual tiredness, decrease in appetite, runny nose, vomiting, irritability, diarrhea, flaring of the nostrils\*, straining of the chest or stomach while breathing\*, or turning blue around the lips and fingertips\*) and must present within 6 days of symptoms onset. Participant must still be exhibiting symptoms on the day of sample collection.
\* These symptoms (i.e. flaring of the nostrils, straining of the chest or stomach while breathing or turning blue around the lips and fingertips) may be signs of possible severe RSV infection or advanced disease such as bronchiolitis, pneumonia and possible progression to respiratory failure and participants should seek medical attention immediately.
You may not be if
1. Participant who has had a positive SARS-CoV-2, Influenza A, Influenza B and/or RSV result within the past 14 days.
2. Participant or participant's legally acceptable representative (for minors) 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.
3. Participant has had seasonal influenza, SARS-CoV-2, and/or RSV vaccine within the past 5 days.
4. Participant is not able to tolerate sample collection, or is not willing to contribute the required swab samples for testing or complete the study procedures.
5. Participant is currently undergoing antiviral treatment such as baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), peramivir (Rapivab®), and ribavirin (Copegus®, Rebetol®, Virazole®).
6. Participant is currently undergoing treatment with prescription medication to treat RSV which may include antiviral treatment such as Ribavirin (tribavirin) or monoclonal antibodies such as Palivizumab (Synagis) and Nirsevimab (Beyfortus).
7. Participant currently undergoing treatment and/or has undergone treatment 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.
8. Participant who has 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.
9. Participant who has had recent craniofacial injury or surgery, including to correct deviation of the nasal septum, within the previous six (6) months.
Clareo Health | Usability and Clinical Validation of the Flu A/B/COVID-19 + RSV Multiplex Rapid Test
