BinaxNow COVID-19 IgG Rapid Test Device and Antibody Self Test
- Conditions
- COVID-19 Respiratory Infection
- Interventions
- Diagnostic Test: The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2.
- Registration Number
- NCT04959760
- Lead Sponsor
- Abbott Rapid Diagnostics Jena GmbH
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 263
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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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BinaxNow Covid-19 Antibody test The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2. The BinaxNOW™ Antibody Tests measure SARS-CoV-2 S-IgG antibodies.
- Primary Outcome Measures
Name Time Method Clinical performance of the BinaxNOW™ COVID-19 IgG Rapid Test 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.
Clinical performance of the BinaxNOW™ COVID-19 Antibody Self-Test 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.
- Secondary Outcome Measures
Name Time Method Diagnostic sensitivity and specificity 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.
Self Test user usability 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.
Professional user usability 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
Matrix Equivalence Professional Use 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.
Trial Locations
- Locations (4)
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Duke University Health System
🇺🇸Durham, North Carolina, United States
Urgent Care Clinical Trials
🇺🇸Dallas, Texas, United States
Urgent Care Clinical Trials at Complete Health Partners
🇺🇸Nashville, Tennessee, United States