Clinical trial NCT04959760: BinaxNow COVID-19 IgG Rapid Test Device and Antibody Self Test
Official title: Clinical Evaluation of the BinaxNOW™ COVID-19 IgG Rapid Test Device and the BinaxNOW™ COVID-19 Antibody Self Test Clinical Study Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Respiratory Infection
Lead sponsor: Abbott Rapid Dx
Sponsor class: INDUSTRY
First posted: 2021-07-13
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical performance of the BinaxNOW™ COVID-19 IgG Rapid Test
timeFrame: Through study completion, an average of 6 months
measure: Clinical performance of the BinaxNOW™ COVID-19 Antibody Self-Test
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Professional user usability
timeFrame: Through study completion, an average of 6 months
measure: Self Test user usability
timeFrame: Through study completion, an average of 6 months
measure: Matrix Equivalence Professional Use
timeFrame: Through study completion, an average of 6 months
measure: Diagnostic sensitivity and specificity
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Powdersville
country: United States
facility: Urgent Care Clinical Trials
state: South Carolina
city: Nashville
country: United States
facility: Urgent Care Clinical Trials at Complete Health Partners
state: Tennessee
city: Dallas
country: United States
facility: Urgent Care Clinical Trials
state: Texas
Study officials:
affiliation: Abbott
name: Simon Kordowich
role: STUDY_DIRECTOR
References: