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

NCT04959760 | Completed FDA Device

• 1 other identifier: CLDG-0511
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

COVID-19 Respiratory Infection

Outcome Measures

Primary Outcomes (2)

• Clinical performance of the BinaxNOW™ COVID-19 IgG Rapid Test

  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

  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 Outcomes (4)

• Professional user usability

  Through study completion, an average of 6 months

• Self Test user usability

  Through study completion, an average of 6 months

• Matrix Equivalence Professional Use

  Through study completion, an average of 6 months

• Diagnostic sensitivity and specificity

  Through study completion, an average of 6 months

Study Arms (1)

BinaxNow Covid-19 Antibody test

EXPERIMENTAL

The BinaxNOW™ Antibody Tests measure SARS-CoV-2 S-IgG antibodies.

Diagnostic Test: The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2.

Interventions

The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2. DIAGNOSTIC_TEST

The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2 in fingestick capillary blood and plasma samples.

BinaxNow Covid-19 Antibody test

Eligibility Criteria

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

You may qualify if:

• Participant is 18 years of age or older.
• 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.
• Participant agrees to complete all aspects of the study.

You may not qualify if:

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

Sponsors & Collaborators

• Abbott Rapid Diagnostics Jena GmbH: lead

Study Sites (5)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Duke University Health System

Durham, North Carolina, 27705, United States

Location

Urgent Care Clinical Trials

Powdersville, South Carolina, 29611, United States

Location

Urgent Care Clinical Trials at Complete Health Partners

Nashville, Tennessee, 37209, United States

Location

Urgent Care Clinical Trials

Dallas, Texas, 75204, United States

Location

Study Officials

• Simon Kordowich

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Operator of the device will be blinded to the outcome
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 13, 2021
• Study Start: June 3, 2021
• Primary Completion: January 20, 2022
• Study Completion: January 20, 2022
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)