Prospective, multi-center, observational, blinded clinical trial to compare a new point of care (POC) SARS-CoV-2 IgG antibody test to a reference SARS-CoV-2 PCR test using fingerstick whole blood.
Patients with PCR testing in outpatient setting will be screened and asked to participate in
the study.
Subjects with a positive diagnosis of COVID-19 confirmed by a positive, EUA SARS-CoV-2 PCR
test will be stratified by the number of days since first symptom onset (i.e. 0-7, 8-14, or
>15 days) in the positive cohort Subjects with a negative diagnosis of COVID-19 confirmed by
a negative, EUA SARS-CoV-2 PCR test within 0-7 days of PCR sample collection will be included
in the negative cohort.
Treating clinicians, clinical research coordinators and study subjects will be blinded to the
POC test results.
Quality assurance will be assured with site monitoring to check accuracy and completeness of
data entered.
Diagnostic Test: POC SARS-Cov-2 IgG Antibody test
All patients will undergo a Point of care (POC) SARS-Cov-2 IgG Antibody test in fingerstick whole blood
Positive Cohort
Inclusion Criteria:
- Patients with high-sensitive EUA PCR results (positive result)
- Previous diagnostic of SARS-Cov-2
- Signed informed consent
Exclusion Criteria:
- Missing PCR results
- Results from a non-high-sensitive PCR test
Negative Cohort
Inclusion Criteria:
- Patients with high-sensitive EUA PCR results (negative result)
- Signed informed consent
Exclusion Criteria:
- Missing PCR results
- Results from a non-high-sensitive PCR test
- Previous diagnostic of SARS-Cov-2
- History of a positive SARS-CoV-2 antibody test (IgG, IgM or Total Antibody)
- Negative SARS-Cov-2 PCR result that occurred > 7 days from study visit
Benchmark - SoCal
Colton, California, United States
Comprehensive Clinical Research
West Palm Beach, Florida, United States
Great Lakes Clinical Trials (GLCT)
Chicago, Illinois, United States