BinaxNow COVID-19 IgG Rapid Test Device and Antibody Self Test
NCT ID: NCT04959760
Last Updated: 2022-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
263 participants
INTERVENTIONAL
2021-06-03
2022-01-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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BinaxNow Covid-19 Antibody test
The BinaxNOW™ Antibody Tests measure SARS-CoV-2 S-IgG antibodies.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
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Abbott Rapid Diagnostics Jena GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Simon Kordowich
Role: STUDY_DIRECTOR
Abbott
Locations
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Rush University Medical Center
Chicago, Illinois, United States
Duke University Health System
Durham, North Carolina, United States
Urgent Care Clinical Trials
Powdersville, South Carolina, United States
Urgent Care Clinical Trials at Complete Health Partners
Nashville, Tennessee, United States
Urgent Care Clinical Trials
Dallas, Texas, United States
Countries
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Other Identifiers
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CLDG-0511
Identifier Type: -
Identifier Source: org_study_id
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