Status:
COMPLETED
Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 (COVID-19) IgG Antibody Test in Fingerstick Whole Blood
Lead Sponsor:
Lumos Diagnostics
Collaborating Sponsors:
Rapid Pathogen Screening
Conditions:
SARS-Cov-2, Covid19
Eligibility:
All Genders
1+ years
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...
Eligibility Criteria
Inclusion
- Positive Cohort
- Patients with high-sensitive EUA PCR results (positive result)
- Previous diagnostic of SARS-Cov-2
- Signed informed consent
Exclusion
- 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
Key Trial Info
Start Date :
January 5 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 9 2021
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT04699903
Start Date
January 5 2021
End Date
April 9 2021
Last Update
June 18 2021
Active Locations (3)
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1
Benchmark - SoCal
Colton, California, United States, 92324
2
Comprehensive Clinical Research
West Palm Beach, Florida, United States, 33409
3
Great Lakes Clinical Trials (GLCT)
Chicago, Illinois, United States, 60640