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

Abbott

Status: Completed

Conditions: COVID-19 Respiratory Infection

Treatments: Diagnostic Test: The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2.

Study type: Interventional

Funder types: Industry

Identifiers

NCT04959760

CLDG-0511

Details and patient eligibility

About

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.

Enrollment: 263 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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263 participants in 1 patient group

BinaxNow Covid-19 Antibody test

Experimental group

Description:

The BinaxNOW™ Antibody Tests measure SARS-CoV-2 S-IgG antibodies.

Treatment:

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