Evaluation of Performance of the LumiraDx Influenza A/B + RSV Test at POC Testing Sites
Evaluation of Performance of the LumiraDx Influenza A/B + RSV Test at POC Testing Sites
A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx Influenza A/B + RSV
 Test at Point of Care Testing Sites
The LumiraDx Influenza A/B + RSV Test is a rapid microfluidic immunofluorescence assay for
 use with the LumiraDx instrument for the qualitative detection and differentiation of
 Influenza type A, Influenza type B and respiratory syncytial virus (RSV) viral antigens. The
 test is not intended to detect influenza C antigens. The LumiraDx Influenza A/B + RSV assay
 uses nasal swabs or nasopharyngeal swab specimens, collected from symptomatic patients.

 Approximately 2000 subjects will be enrolled in this study. 120 influenza A positive, 120
 influenza B positive and 120 RSV positive samples are required, in addition to at least 120
 samples negative for influenza and 120 negative RSV samples, representing four (4) age
 groups: ≤ 5 years, 6 to 21 years, 22 to 59 years, and ≥ 60 years. Depending on the prevalence
 of influenza A, influenza B or RSV, it will be necessary to collect a significantly higher
 number of total samples to obtain the required number of positives. Banked specimens may be
 used to supplement the data set.

 The objectives of this clinical study are twofold:

 -  Evaluate the performance of the LumiraDx Influenza A/B + RSV Test in detecting and
 differentiating influenza A, influenza B and RSV in fresh nasal or nasopharyngeal swab
 specimens from patients with signs and symptoms of influenza and or RSV-like illness, as
 compared with an FDA-cleared comparative method.

 -  Evaluate LumiraDx Influenza A/B + RSV Test performance when the test is run by
 non-laboratory users in point-of-care (POC) locations representative of sites who
 perform testing under a CLIA certificate of waiver.
Inclusion Criteria:

 -  The subject may be of any age and either sex.

 -  Preliminary assessment of the subject by the Investigator/designee should be
 suggestive of influenza and/or RSV at the time of the study visit. The subject must
 exhibit two (2) or more of the following signs and symptoms for eligibility: stuffy or
 runny nose, sneezing, cough, sore throat, dyspnea (labored, difficult breathing),
 wheezing, fatigue, weakness and/or malaise, arthralgia (joint pain), myalgia (deep
 muscle aches), anorexia, vomiting, diarrhea, or headache. The onset of these symptoms
 must 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 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 18 years and older must report having a
 fever, 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 during
 this study visit.

 -  The subject is undergoing treatment currently and/or within the past 14 days of the
 study 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 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).

 -  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.

 -  The subject has previously participated in this research study