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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 1 Year
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT04699903
Status
Completed
Sponsor
Lumos Diagnostics

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.