NCT04699903

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 201 (actual)
• Sponsor: Lumos Diagnostics · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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.

Conditions

• SARS-Cov-2, Covid19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-01-05
• Primary completion: 2021-01-29
• Completion: 2021-04-09
• First posted: 2021-01-07
• Last updated: 2021-06-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study