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

SARS-Cov-2, Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04699903
• Other study ID #: 20-1106
• Status: Completed
• Start date: January 5, 2021
• Est. completion date: April 9, 2021

Study information

• Verified date: June 2021
• Source: Lumos Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: April 9, 2021
• Est. primary completion date: January 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• SARS-Cov-2, Covid19

Intervention

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

Locations

Country	Name	City	State
United States	Great Lakes Clinical Trials (GLCT)	Chicago	Illinois
United States	Benchmark - SoCal	Colton	California
United States	Comprehensive Clinical Research	West Palm Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Lumos Diagnostics	Rapid Pathogen Screening

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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