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Inclusion Criteria:

* 1\. The subject may be of any age and either sex.
* 2\. Preliminary assessment of the subject by the Investigator/designee should be suggestive of COVID-19 at the time of the study visit. The subject must present as symptomatic, meaning they have exhibited one or more of the following signs and symptoms for eligibility: fever, cough, shortness of breath, difficulty breathing, muscle pain, headache, sore throat, chills, repeated shaking with chills, new loss of taste or smell. The onset of these symptoms will be recorded.

or The subject must have a documented SARS-CoV-2 PCR test in the past 48 hours.

* 3\. Written informed consent must be obtained prior to study enrollment.

  1. A subject who is eighteen (18) years or older must be willing to give written informed consent and must agree to comply with study procedures.
  2. The Legal Guardian or Legal Authorized Representative of a subject who is under the age of eighteen (18) must give written informed consent and agree to comply with study procedures. Active written assent should be obtained from children of appropriate intellectual age (as defined by the IRB).

Exclusion Criteria:

* 1\. The subject underwent a nasal wash/aspirate as part of standard of care testing during this study visit.
* 2\. The subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, drug, or device including either treatment or therapy.
* 3\. The subject has previously participated in this research study

• Altamonte Springs, Florida, United States
• Kissimmee, Florida, United States
• Atlanta, Georgia, United States
• Millersville, Maryland, United States
• Winston-Salem, North Carolina, United States
• Jackson, Tennessee, United States
• Plano, Texas, United States