Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag Test
Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag Test
Performance of the LumiraDx SARS-CoV-2 Ag assay will be assessed by comparison to a reference
 method.
The study is a prospective, multi-center study. One (1) reference laboratory and
 approximately six (6) geographically diverse POC (Point of Care) locations (e.g. physician
 office laboratories, urgent cares, emergency departments, outpatient clinics, drive through
 testing sites or research centers) in the U.S. will participate in the study. Testing in the
 reference laboratory will be performed by trained laboratory personnel. Testing at the POC
 sites will be performed by non-laboratory health professionals who are representative of
 typical intended use operators (e.g. nurses, physician assistants, medical assistants, etc.).
 Each site will have a minimum of one (1) untrained intended use operator who will perform
 testing under this protocol.

 A subject's participation in this study will consist of a single visit. Following completion
 of the informed consent process and a review of Inclusion/Exclusion criteria to determine
 eligibility, each subject will receive a unique study identification number.

 Subjects will have nasopharyngeal or nasal or throat swabs collected. Capillary blood may be
 collected alongside nasal swabs. Saliva samples may also be collected. Specimens will be
 obtained from each subject enrolled using standard collection methods.

 The LumiraDx SARS-CoV-2 Ag Test will be performed at POC sites by intended use operators
 (e.g. nurses, physician assistants, medical assistants, etc.). Each site will have a minimum
 of one (1) untrained intended use operator who will perform testing under this protocol.

 The LumiraDx SARS-CoV-2 Ag Test will be performed at the site on the same day as the date of
 collection using one swab for each subject enrolled. A central laboratory will perform
 reference testing.

 Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) will be estimated for
 the LumiraDx SARS-CoV-2 Ag Test results as compared with the reference Test.

 A minimum of thirty (30) positive SARS-CoV-2 are required, but it is likely because of the
 prevalence of SARS-CoV-2 in the population, that a greater number of negatives will be
 obtained during the prospective collection of positive samples; therefore, approximately
 four-hundred (400) subjects will be enrolled. A minimum of thirty (30) negative samples are
 required.
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