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

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Evaluation of the BinaxNOW™ COVID-19 IgG Rapid Test Device and the BinaxNOW™ COVID-19 Antibody Self Test Clinical Study Protocol

Conditions
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COVID-19 Respiratory Infection

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


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BinaxNow Covid-19 Antibody test<br>The BinaxNOW™ Antibody Tests measure SARS-CoV-2 S-IgG antibodies. | Diagnostic Test: The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2.<br>* The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2 in fingestick capillary blood and plasma samples.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |