Official Title
Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 IgG Antibody Test in Fingerstick Whole Blood
Brief Summary

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.

Detailed Description

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.

Completed
SARS-Cov-2, Covid19

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

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 1 Year ~ Maximum: N/A
Countries
United States
Locations

Benchmark - SoCal
Colton, California, United States

Comprehensive Clinical Research
West Palm Beach, Florida, United States

Great Lakes Clinical Trials (GLCT)
Chicago, Illinois, United States

Rapid Pathogen Screening
NCT Number
Keywords
IgG
Point of Care Testing
EUA
MeSH Terms
COVID-19
Antibodies
Immunoglobulin G