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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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SARS-Cov-2, Covid19

Intervention / Treatment
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* Diagnostic Test: POC SARS-Cov-2 IgG Antibody test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Positive SARS-Cov-2 cohort<br>Positive diagnosis of COVID-19 confirmed by a positive EUA SARS-CoV-2 PCR will be stratified in three subgroups 0 - 7 days since onset of symptoms 8 - 14 days since onset of symptoms 15 -90 days since onset of symptoms | Diagnostic Test: POC SARS-Cov-2 IgG Antibody test<br>* All patients will undergo a Point of care (POC) SARS-Cov-2 IgG Antibody test in fingerstick whole blood<br>|
| Negative SARS-Cov-2 cohort<br>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. | Diagnostic Test: POC SARS-Cov-2 IgG Antibody test<br>* All patients will undergo a Point of care (POC) SARS-Cov-2 IgG Antibody test in fingerstick whole blood<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PPA (positive percent agreement) and NPA (negative percent agreement) of POC compared to SARS-CoV-2 reference PCR | Determine PPA and NPA of point of care (POC) SARS-CoV-2 IgG antibody test compared to SARS-CoV-2 PCR with EUA (FDA emergency use authorization) | 0-7 days | 
| PPA (positive percent agreement) of POC compared to SARS-CoV-2 reference PCR | Determine PPA of point of care (POC) SARS-CoV-2 IgG antibody test compared to SARS-CoV-2 PCR with EUA (FDA emergency use authorization) | 8-14 days | 
| PPA (positive percent agreement) of POC compared to SARS-CoV-2 reference PCR | Determine PPA of point of care (POC) SARS-CoV-2 IgG antibody test compared to SARS-CoV-2 PCR with EUA (FDA emergency use authorization) | 15 - 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IgG, Point of care testing, EUA