Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 (COVID-19) IgG Antibody Test in Fingerstick Whole Blood

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

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.

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