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

NCT04902911 | Terminated FDA Device

• 1 other identifier: PRO00039709
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

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 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

Keywords

covid 19; antibody; IgM; IgG

Outcome Measures

Primary Outcomes (1)

• Novir 2019-nCoV IgG/IgM Antibody test

  To determine the sensitivity and specificity of the Novir 2019-nCoV IgM/IgG Antibody Test (Colloidal Gold) when testing intended use populations who meet the criteria of having COVID-19 infection by Centers for Disease Control and Prevention (CDC). The test is to be performed by healthcare professionals (non-CLIA laboratory technicians) at POC settings.vStandard calculations will be used to derive sensitivity, specificity, positive and negative predictive values as well as 95% confidence intervals compared to reference method.

  2 years

Study Arms (2)

Antigen testing in those who have history of COVID-19

Individuals must have had history of COVID-19. Finger stick point of care test will be performed which results in 10 minutes indicating if there is detection of a control, IgG and IgM. Control line must be present for test to be considered valid. 3mL of venous whole blood will be collected from patient in which the research team will perform the SARS-CoV-2 antibody test.

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

Antigen testing in those who do not have history of COVID-19 and COVID immunization

Individuals may not have history of COVID-19 and COVID immunizations in order to be eligible. Finger stick point of care test will be performed which results in 10 minutes indicating if there is detection of a control, IgG and IgM. Control line must be present for test to be considered valid. 3mL of venous whole blood will be collected from patient in which the research team will perform the SARS-CoV-2 antibody test.

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

Interventions

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

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

Antigen testing in those who do not have history of COVID-19 and COVID immunization; Antigen testing in those who have history of COVID-19

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any subject willing to participate since status for previous infection is not needed.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Novir: collaborator

Study Sites (1)

Froedtert Health WAC

Wauwatosa, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pathology

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 26, 2021
• Study Start: April 13, 2021
• Primary Completion: August 17, 2022
• Study Completion: August 17, 2022
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)