Evaluation of Performance of the LumiraDx Influenza A/B + RSV Test at POC Testing Sites

Inclusion Criteria:

• The subject may be of any age and either sex.
• Preliminary assessment of the subject by the Investigator/designee should besuggestive of influenza and/or RSV at the time of the study visit. The subject mustexhibit two (2) or more of the following signs and symptoms for eligibility: stuffy orrunny nose, sneezing, cough, sore throat, dyspnea (labored, difficult breathing),wheezing, fatigue, weakness and/or malaise, arthralgia (joint pain), myalgia (deepmuscle aches), anorexia, vomiting, diarrhea, or headache. The onset of these symptomsmust not have begun more than four (4) days prior to study enrollment.
• The subject must have a fever of 100.0 °F or greater with the onset of the fever beingwithin the past three (3) days and/or present at the time of the visit. Fever can bereported or taken at time of visit. Subjects 18 years and older must report having afever, but a quantitative reported measurement is not necessary for inclusion.

Exclusion Criteria:

• The subject underwent a nasal wash/aspirate as part of standard of care testing duringthis study visit.
• The subject is undergoing treatment currently and/or within the past 14 days of thestudy visit with an inhaled influenza vaccine (FluMist®) or anti-viral medication,which may include but is not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), or Baloxavir Marboxil (Xofluza™).
• The subject is undergoing treatment currently or had undergone within the past 14 daysof the study visit with RSV-related medication which may include but is not limited toRibavirin (Virazole), RSV-IGIV (RespiGam) or palivizumab (Synagis).
• The subject is currently receiving or has received within the past thirty (30) days ofthe study visit an experimental biologic, drug, or device including either treatmentor therapy.
• The subject has previously participated in this research study