Performance of the LumiraDx SARS-CoV-2 Ag ULTRA 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. Specimens will be
obtained from each subject enrolled using standard collection methods.
The LumiraDx SARS-CoV-2 Ag ULTRA 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 ULTRA 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 ULTRA 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
Inclusion Criteria
1. Subject may be of any age or gender.
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 congestion or runny nose, diarrhea, nausea or vomiting. The onset
of these symptoms will be recorded and will be within the last twelve (12) days.
or The subject is asymptomatic and is neither currently exhibiting signs or symptoms
of SARS-CoV-2 nor has experienced signs or symptoms within the past fourteen (14)
days, and has not knowingly been exposed to someone with a positive test result
within the last fourteen (14) days
3. Participant (or parent/legal guardian) capable and willing to give informed
consent/assent.
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. Subjects undergoing treatment currently and/or within the past thirty (30) days of
the study with medication to treat novel Coronavirus SARS-CoV-2 like illness
symptoms, which may include but is not limited to Remdesivir or convalescent plasma
therapy for SARS-CoV-2.
4. The subject has previously participated in this research study.
Cahaba Research, Inc.
Birmingham, Alabama, United States
Advanced Investigative Medicine
Hawthorne, California, United States
Healthy Life Research, Inc.
Miami, Florida, United States
The Machuca Foundation, Inc.
Las Vegas, Nevada, United States
Cyn3rgy Research
Gresham, Oregon, United States
Zion Urgent Care
Katy, Texas, United States