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.
Diagnostic Test: Nasal Swab
Collection of one more nasal swabs
Diagnostic Test: Nasopharyngeal swab
Collection of one more nasopharyngeal swabs
Diagnostic Test: Throat swab
Collection of one more throat swabs
Diagnostic Test: Fingerstick
Collection of capillary blood from one or more fingersticks
Diagnostic Test: Saliva specimen
Collection of free drool
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
Children's Pediatric Associates of Altamonte Springs
Altamonte Springs, Florida, United States
Chappel Group
Kissimmee, Florida, United States
Good Samaritan Minute Clinic, Georgia Tech
Atlanta, Georgia, United States
Gvozden Pediatrics
Millersville, Maryland, United States
Ardmore Family Practice
Winston-Salem, North Carolina, United States
Physicians Quality Care of Jackson
Jackson, Tennessee, United States
Village Health Partners
Plano, Texas, United States