Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 (COVID-19) IgG Antibody Test in Fingerstick Whole Blood
Completed
Conditions studied: SARS-Cov-2, Covid19
In brief
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.
Key facts
- Study ID
- NCT04699903
- Run by
- Lumos Diagnostics
- People needed
- 201
- Starts
- 2021-01-05
- Expected to finish
- 2021-04-09
- Last updated by the study team
- 2021-06-18
Who can join
Age: 1 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with high-sensitive EUA PCR results (positive result)
- Previous diagnostic of SARS-Cov-2
- Signed informed consent
You may not qualify if…
- 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
Where it is running
- Benchmark - SoCal — Colton, California, United States
- Comprehensive Clinical Research — West Palm Beach, Florida, United States
- Great Lakes Clinical Trials (GLCT) — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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