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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BinaxNow Covid-19 Antibody test | Experimental | The BinaxNOW™ Antibody Tests measure SARS-CoV-2 S-IgG antibodies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Professional user usability | 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 |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon Kordowich | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States | ||
| Duke University Health System |
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Operator of the device will be blinded to the outcome
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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 | 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 | 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 |
| Durham |
| North Carolina |
| 27705 |
| United States |
| Urgent Care Clinical Trials | Powdersville | South Carolina | 29611 | United States |
| Urgent Care Clinical Trials at Complete Health Partners | Nashville | Tennessee | 37209 | United States |
| Urgent Care Clinical Trials | Dallas | Texas | 75204 | United States |