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

Completed

• Conditions: SARS-Cov-2, Covid19
• Interventions: Diagnostic Test: POC SARS-Cov-2 IgG Antibody test

• Registration Number: NCT04699903
• Lead Sponsor: Lumos Diagnostics

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.

Study Timeline

• Study First Submitted: 2020-12-29
• Study Start: 2021-01-05
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-07
• Primary Completion: 2021-01-29
• Study Completion: 2021-04-09
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-15
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Positive SARS-Cov-2 cohort	POC SARS-Cov-2 IgG Antibody test	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
Negative SARS-Cov-2 cohort	POC SARS-Cov-2 IgG Antibody test	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.

Primary Outcome Measures

Name	Time	Method
PPA (positive percent agreement) and NPA (negative percent agreement) of POC compared to SARS-CoV-2 reference PCR	0-7 days	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)
PPA (positive percent agreement) of POC compared to SARS-CoV-2 reference PCR	15 - 90 days	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)

Trial Locations

Locations (3)

Benchmark - SoCal; 🇺🇸 Colton, California, United States

Comprehensive Clinical Research; 🇺🇸 West Palm Beach, Florida, United States

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