BinaxNow COVID-19 IgG Rapid Test Device and Antibody Self Test

May 6, 2022 updated by: Abbott Rapid Diagnostics Jena GmbH

Clinical Evaluation of the BinaxNOW™ COVID-19 IgG Rapid Test Device and the BinaxNOW™ COVID-19 Antibody Self Test Clinical Study Protocol

Performance evaluation of the BinaxNOW™ COVID-19 IgG Rapid Test Device (Professional Use) and with BinaxNOW™ COVID-19 Antibody Self Test wehn used with fingerstick capillary whole blood and plasma samples. The BinaxNOW™ Antibody Tests are lateral flow tests that measure SARS-CoV-2 IgG antibodies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

263

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Health System
    • South Carolina
      • Powdersville, South Carolina, United States, 29611
        • Urgent Care Clinical Trials
    • Tennessee
      • Nashville, Tennessee, United States, 37209
        • Urgent Care Clinical Trials at Complete Health Partners
    • Texas
      • Dallas, Texas, United States, 75204
        • Urgent Care Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Participant is 18 years of age or older.

  2. Evaluable individuals with a prior confirmed SARS-CoV-2 infection with prior COVID-19 symptoms with symptoms onset > 14 days prior to the study, or symptoms onset 8-14 days prior to the study, or symptoms onset 0-7 days prior to study.OR

    Evaluable individuals confirmed negative by SARS-CoV-2 RT-PCR using a sample obtained within 7 days prior to or on the day of the study.

  3. Participant agrees to complete all aspects of the study.

Exclusion Criteria:

  1. Participant has already participated in this study on a previous occasion.
  2. Participant is enrolled in a study to evaluate a new drug.
  3. Participant has a visual impairment that cannot be restored using glasses or contact lenses.
  4. Participant is unable or unwilling to provide informed consent.
  5. Participant is a vulnerable person as deemed unfit for the study by the Principal Investigator.
  6. Participant has a condition deemed unfit to safely perform the test by the investigator.
  7. Participant is a practising health-care professional or laboratory scientist / technician.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BinaxNow Covid-19 Antibody test
The BinaxNOW™ Antibody Tests measure SARS-CoV-2 S-IgG antibodies.
Diagnostic test: The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2.
The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2 in fingestick capillary blood and plasma samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance of the BinaxNOW™ COVID-19 IgG Rapid Test
Time Frame: Through study completion, an average of 6 months
to evaluate the clinical performance of the BinaxNOW™ COVID-19 IgG Rapid Test Device when used by a professional user.
Through study completion, an average of 6 months
Clinical performance of the BinaxNOW™ COVID-19 Antibody Self-Test
Time Frame: Through study completion, an average of 6 months
to evaluate the clinical performance of the BinaxNOW™ COVID-19 Antibody Self-Test when used by a lay person.
Through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Professional user usability
Time Frame: Through study completion, an average of 6 months
Evaluation of the usability of the BinaxNOW™ COVID-19 IgG Rapid Test Device when used by a Professional User
Through study completion, an average of 6 months
Self Test user usability
Time Frame: Through study completion, an average of 6 months
Evaluation of the usability of the BinaxNOW™ COVID-19 Antibody Self-Test when used by a lay person.
Through study completion, an average of 6 months
Matrix Equivalence Professional Use
Time Frame: Through study completion, an average of 6 months
Validation of the Matrix Equivalence between the Fingerstick Whole Blood and Plasma samples when used with the BinaxNOW COVID-19 IgG Rapid Test Device.
Through study completion, an average of 6 months
Diagnostic sensitivity and specificity
Time Frame: Through study completion, an average of 6 months
To determine the diagnostic sensitivity, specificity and overall agreement of the BinaxNOW™ COVID-19 Antibody Self Test as performed by lay users in comparison with the BinaxNOW™ COVID-19 IgG Rapid Test Device as performed by professional user.
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Rapid Diagnostics Jena GmbH

Investigators

  • Study Director: Simon Kordowich, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2021

Primary Completion (Actual)

January 20, 2022

Study Completion (Actual)

January 20, 2022

Study Registration Dates

First Submitted

July 1, 2021

First Submitted That Met QC Criteria

July 12, 2021

First Posted (Actual)

July 13, 2021

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 6, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLDG-0511

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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