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

June 15, 2021 updated by: Lumos Diagnostics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

201

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Colton, California, United States, 92324
        • Benchmark - SoCal
    • Florida
      • West Palm Beach, Florida, United States, 33409
        • Comprehensive Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials (GLCT)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients in the outpatient setting with EUA PCR test results who meet inclusion and exclusion criteria are eligible for the study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Positive SARS-Cov-2 cohort
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
All patients will undergo a Point of care (POC) SARS-Cov-2 IgG Antibody test in fingerstick whole blood
Negative SARS-Cov-2 cohort
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
All patients will undergo a Point of care (POC) SARS-Cov-2 IgG Antibody test in fingerstick whole blood

What is the study measuring?

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
Time Frame: 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)
0-7 days
PPA (positive percent agreement) of POC compared to SARS-CoV-2 reference PCR
Time Frame: 8-14 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)
8-14 days
PPA (positive percent agreement) of POC compared to SARS-CoV-2 reference PCR
Time Frame: 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)
15 - 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lumos Diagnostics

Collaborators

Rapid Pathogen Screening

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 5, 2021

Primary Completion (ACTUAL)

January 29, 2021

Study Completion (ACTUAL)

April 9, 2021

Study Registration Dates

First Submitted

December 29, 2020

First Submitted That Met QC Criteria

January 6, 2021

First Posted (ACTUAL)

January 7, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 15, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-1106

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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