Clinical Evaluation of the BinaxNOW™ COVID-19 IgG Rapid Test Device and the BinaxNOW™ COVID-19 Antibody Self Test Clinical Study Protocol
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 263
- Locations
- 9
- Primary Endpoint
- Clinical performance of the BinaxNOW™ COVID-19 IgG Rapid Test
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Masking Description
Operator of the device will be blinded to the outcome
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Clinical performance of the BinaxNOW™ COVID-19 IgG Rapid Test
Time Frame: 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
Time Frame: 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 Outcomes
- Diagnostic sensitivity and specificity(Through study completion, an average of 6 months)
- Self Test user usability(Through study completion, an average of 6 months)
- Professional user usability(Through study completion, an average of 6 months)
- Matrix Equivalence Professional Use(Through study completion, an average of 6 months)