Status:
TERMINATED
Point of Care Evaluation of Novir 2019-nCoV Immunoglobulin G/ Immunoglobulin M (IgG/IgM) Antibody Test (Collodial Gold)
Lead Sponsor:
Medical College of Wisconsin
Collaborating Sponsors:
Novir
Conditions:
Covid19
Eligibility:
All Genders
21+ years
Brief Summary
This clinical study is designed to test the efficacy of the Novir 2019-nCoV Immunoglobulin M/Immunoglobulin G Antibody Test in a point-of-care setting to support the increasing need for rapid screenin...
Detailed Description
This clinical study is designed to test the efficacy and robustness of the Novir 2019-nCoV IgM/IgG Antibody Test (Colloidal Gold) in a point-of-care (POC) setting to support the growing need for rapid...
Eligibility Criteria
Inclusion
- Must be 21 years old or older.
- Must be able to provide finger stick and venous whole blood samples.
- Must be able to understand and sign a consent form.
- Must be able to provide an additional sample(s) required by the study site for an additional FDA EUA authorized antibody testing (ELISA, CMIA, or other antibody test).
- Has an immediate need to determine COVID-19 status for occupational purposes.
- Was exposed to a COVID-19 patient within 7 days that leads the healthcare provider to suspect the individual of possibly having SARS-CoV-2 infection.
- Has symptoms that lead the healthcare provider to suspect the individual of possibly having SARS-CoV-2 infection.
- Has had a positive FDA EUA authorized PCR test between 1-28 days with or without symptom expression.
- Individuals who have tested positive for COVID-19 infection and have antibodies detected must have agreed to participate in the MCW Tissue Bank COVID-19 banking project.
Exclusion
- Is receiving treatment with infusion of convalescent plasma or other antibody therapy related to SARS-CoV-2 infections.
- Tested negative for COVID-19 by PCR more than 7 days ago.
- Is participating in a SARS-CoV-2 vaccine study.or received any doses of the available SARS-CoV-2 vaccines.
- Previously tested positive for COVID-19 at any point in time (for asymptomatic patients enrolling in the negative patient population).
Key Trial Info
Start Date :
April 13 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 17 2022
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT04902911
Start Date
April 13 2021
End Date
August 17 2022
Last Update
January 8 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Froedtert Health WAC
Wauwatosa, Wisconsin, United States, 53226