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

Primary Purpose

Covid19

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COVID-19 SARS-CoV IgG/IgM antibody rapid test
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Covid19 focused on measuring covid 19, antibody, IgM, IgG

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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).

Sites / Locations

  • Froedtert Health WAC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Antigen testing in those who have history of COVID-19

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

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 21, 2021
Last Updated
March 13, 2023
Sponsor
Medical College of Wisconsin
Collaborators
Novir
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1. Study Identification

Unique Protocol Identification Number
NCT04902911
Brief Title
Point of Care Evaluation of Novir 2019-nCoV Immunoglobulin G/ Immunoglobulin M (IgG/IgM) Antibody Test (Collodial Gold)
Acronym
NOVIR POC
Official Title
Point of Care Evaluation of Novir 2019-nCoV Immunoglobulin G/ Immunoglobulin M (IgG/IgM) Antibody Test (Collodial Gold)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Failed to meet FDA criteria on one target at FDA, CDC, and market is not looking for rapid antibody tests.
Study Start Date
April 13, 2021 (Actual)
Primary Completion Date
August 17, 2022 (Actual)
Study Completion Date
August 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Novir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
covid 19, antibody, IgM, IgG

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antigen testing in those who have history of COVID-19
Arm Type
Experimental
Arm Description
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.
Arm Title
Antigen testing in those who do not have history of COVID-19 and COVID immunization
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
COVID-19 SARS-CoV IgG/IgM antibody rapid test
Intervention Description
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
Primary Outcome Measure Information:
Title
Novir 2019-nCoV IgG/IgM Antibody test
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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).
Facility Information:
Facility Name
Froedtert Health WAC
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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