Performance Evaluation of LumiraDx SARS-CoV-2, Flu A/B, and RSV Tests for COVID-19 Assessment

1. Preliminary assessment of the subject by the Investigator/designee should be suggestive of COVID-19 and /or influenza and/or RSV at the time of the study visit.

2. The subject must present in one of the following two cohorts:

   Covid Cohort:

   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, congestion or runny nose, diarrhea, nausea or vomiting. The onset of these symptoms will be recorded and will be in the last twelve (12) days.

   or The subject must have presented with respiratory symptoms and a documented positive SARS-CoV-2 PCR or antigen test in the past forty-eight (48) hours.

   Influenza/RSV Cohort:

   The subject must have a fever of 100.0 °F or greater with the onset of the fever being within the past three (3) days and/or present at the time of the visit. Fever can be reported or taken at time of visit. Subjects must report having a fever, but a quantitative reported measurement is not necessary for inclusion. In addition to the fever, the subject must have two (2) or more of the following signs and symptoms for eligibility: cough, shortness of breath, difficulty breathing, muscle pain, joint pain, headache, chills, repeated shaking with chills, congestion or runny nose, diarrhea, nausea, vomiting, sneezing, sore throat, wheezing, fatigue, weakness and/or malaise or anorexia. The onset of these symptoms will be recorded and will be in the last four (4) days. OR The subject must have presented with respiratory symptoms and a documented positive Flu or RSV test in the past forty-eight (48) hours.

3. Written informed consent must be obtained prior to study enrollment. A subject who is a legal adult must be willing to give written informed consent and must agree to comply with study procedures. The Legal Guardian or Legal Authorized Representative of a subject who is under the age of consent must give written informed consent and agree to comply with study procedures. Active 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. Subjects undergoing treatment currently and/or within the past fourteen (14 days of the study visit with an inhaled influenza vaccine (FluMist®) or with antiviral medication, which may include but is not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), or Baloxavir Marboxil (Xofluza™)
3. Subjects undergoing treatment currently and/or within the past thirty (30) days of the study with prescription medication to treat novel Coronavirus SARS-CoV-2 infection, which may include but is not limited to Remdesivir (Veklury) or receiving convalescent plasma therapy for SARS-CoV-2;
4. The subject is undergoing treatment currently or had undergone within the past fourteen (14) days of the study visit with RSV-related medication which may include but is not limited to Ribavirin (Virazole), RSV-IGIV (RespiGam) or palivizumab (Synagis).
5. 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.
6. The subject has previously participated in this research study (CS-1262-01).