Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 (COVID-19) IgG Antibody Test in Fingerstick Whole Blood
NCT ID: NCT04699903
Last Updated: 2021-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
201 participants
OBSERVATIONAL
2021-01-05
2021-04-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Previous diagnostic of SARS-Cov-2
* Signed informed consent
* Patients with high-sensitive EUA PCR results (negative result)
* Signed informed consent
Exclusion Criteria
* Results from a non-high-sensitive PCR test
Negative Cohort
* 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
1 Year
ALL
No
Sponsors
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Rapid Pathogen Screening
INDUSTRY
Lumos Diagnostics
INDUSTRY
Responsible Party
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Locations
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Benchmark - SoCal
Colton, California, United States
Comprehensive Clinical Research
West Palm Beach, Florida, United States
Great Lakes Clinical Trials (GLCT)
Chicago, Illinois, United States
Countries
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Other Identifiers
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20-1106
Identifier Type: -
Identifier Source: org_study_id
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