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

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

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.

Inclusion Criteria:

1. Participant is 18 years of age or older.

2. 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.

3. Participant agrees to complete all aspects of the study.

Exclusion Criteria:

1. Participant has already participated in this study on a previous occasion.
2. Participant is enrolled in a study to evaluate a new drug.
3. Participant has a visual impairment that cannot be restored using glasses or contact lenses.
4. Participant is unable or unwilling to provide informed consent.
5. Participant is a vulnerable person as deemed unfit for the study by the Principal Investigator.
6. Participant has a condition deemed unfit to safely perform the test by the investigator.
7. Participant is a practising health-care professional or laboratory scientist / technician.