Performance of the LumiraDx SARS-CoV-2 Ag assay will be assessed by comparison to areference 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:
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1. The subject may be of any age and either sex.
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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.
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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:
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1. The subject underwent a nasal wash/aspirate as part of standard of care testing
during this study visit.
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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.
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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