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Point of Care Evaluation of Novir 2019-nCoV Immunoglobulin G/ Immunoglobulin M (IgG/IgM) Antibody Test (Collodial Gold)

NCT04902911 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 91

Last updated 2024-01-08

No results posted yet for this study

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 screening in the detection of antibodies. The study is performed on individuals who have no history of COVID-19 and no history of COVID immunization as well as individuals with history of COVID-19 that was diagnosed greater than 15 days. This is performed both through 3mL venous whole blood which is ran through an assay as well a point-of-care rapid test which is resulted in 10 minutes. Aiding in the rapid detection of COVID-19 antibodies.

Conditions

  • Covid19

Interventions

DEVICE

COVID-19 SARS-CoV IgG/IgM antibody rapid test

Needle stick point of care and 3mL vial of blood will be collected and tested for individual without history of COVID-19 and immunization as well as a second group composed of individuals with history of COVID-19

Sponsors & Collaborators

  • Novir

    collaborator UNKNOWN

  • Medical College of Wisconsin

    lead OTHER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-13
Primary Completion
2022-08-17
Completion
2022-08-17
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04902911 on ClinicalTrials.gov