NCT04902911

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 91 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

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 screening of patients to detect antibodies. The COVID-19 SARS-CoV IgM/IgG antibody rapid test is an immunochromatographic lateral flow assay intended for qualitative detection of IgM and IgG antibodies to SARS-CoV-2 in human venipuncture and finger stick whole blood. The COVID-19 SARS-CoV IgM/IgG antibody rapid test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Results are for the detection of SARS CoV-2 antibodies. IgM and IgG antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion. All the results will be compared to an FDA EUA authorized PCR test results and may also be compared to an FDA EUA authorized ELISA, CMIA, or other antibody test. The study results will be used for an EUA application to the FDA.

Conditions

• Covid19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-04-13
• Primary completion: 2022-08-17
• Completion: 2022-08-17
• First posted: 2021-05-26
• Last updated: 2024-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study