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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
263
The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2 in fingestick capillary blood and plasma samples.
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
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.
Time frame: 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.
Time frame: Through study completion, an average of 6 months
Professional user usability
Evaluation of the usability of the BinaxNOW™ COVID-19 IgG Rapid Test Device when used by a Professional User
Time frame: Through study completion, an average of 6 months
Self Test user usability
Evaluation of the usability of the BinaxNOW™ COVID-19 Antibody Self-Test when used by a lay person.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Urgent Care Clinical Trials
Dallas, Texas, United States