Evaluation of the agreement between fingerstick samples, venous blood, serum and plasma samples when using the LumiraDx SARS-CoV-2 Ab Test against the reference method, using standard qualitative comparison techniques.
This is a prospective, multi-centre study. One (1) Reference Lab and approximately six (6)
Healthcare or Research Facilities within geographic areas experiencing current Covid-19
outbreaks in the U.S. will participate in the study. Study sites may be Point of Care (POC)
locations, such as physician office laboratories, urgent care and outpatient clinics, or
dedicated research sites.
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 undergo two (2) fingerstick lancing's and 1 (one) venous blood draw. A total of
eleven (11) tests (LumiraDx SARS-CoV-2 Ab and haematocrit) will then be performed using these
samples. Specimens will be obtained from each subject enrolled using standard collection
methods.
All operators at a site level performing the LumiraDx SARS-CoV-2 Ab POC Test in this study
will be required to complete training detailing the running of the LumiraDx Test/Instrument.
This will be completed as part of a familiarization period and all operators will be required
to show proficiency in using the system for QC, fingerstick, whole blood, plasma and serum
testing prior to testing subjects. This will be captured on relevant training forms as part
of the site initiation visit. In addition, the operator's satisfaction and ease of use of the
LumiraDx SARS-CoV-2 Ab Test will be evaluated by completing an Intended Use Operator
Questionnaire.
The LumiraDx SARS-CoV-2 Ab POC Testing will be performed at the site on the same day as the
date of collection. Samples will be shipped to a central laboratory for reference testing.
Testing in the reference laboratory will be performed by trained laboratory personnel.
Approximately 200 subjects will be enrolled in this study. Approximately thirty (30)
SARS-CoV-2 positive, and thirty (30) samples negative for SARS-CoV-2 will be enrolled at each
site.
Diagnostic Test: Capillary Collection & Testing
Two (2) fingersticks will be performed on each subject and capillary blood tested in the LumiraDx SARS-CoV-2 Ab test
Diagnostic Test: Venous Draw & Testing
One (1) Venous Draw (to include one (1) 6.0 mL EDTA tube and one (1) 3.5 mL serum separator tube) will be collected from each subject. Blood will be tested in the LumiraDx SARS-CoV-2 Ab test
Inclusion Criteria:
1. Male and female subjects aged ≥ 2 years.
2. The subject must have a documented SARS-CoV-2 PCR test in the past 7-30 days.
(subjects must be 14+ days post symptom onset at the time of recruitment).
3. Written informed consent must be obtained prior to study enrollment.
1. A subject who is 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 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. Skin lesions or conditions that would preclude a fingerstick and or a venous blood
draw.
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.
Eclipse Clinical Research
Tucson, Arizona, United States
Centura Health Physician Group, Northglenn Office
Northglenn, Colorado, United States
Professional Research Network of Kansas
Wichita, Kansas, United States
Physicians Quality Care of Jackson
Jackson, Tennessee, United States