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

Lumos Diagnostics

Status: Completed

Conditions: SARS-Cov-2, Covid19

Treatments: Diagnostic Test: POC SARS-Cov-2 IgG Antibody test

Study type: Observational

Funder types: Industry

Identifiers

NCT04699903

20-1106

Details and patient eligibility

About

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.

Full 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.

Enrollment: 201 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

201 participants in 2 patient groups

Positive SARS-Cov-2 cohort

Description:

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

Treatment:

Diagnostic Test: POC SARS-Cov-2 IgG Antibody test

Negative SARS-Cov-2 cohort

Description:

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.

Treatment:

Diagnostic Test: POC SARS-Cov-2 IgG Antibody test