COVID-19 Respiratory Infection
Conditions
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.
Interventions
DIAGNOSTIC_TESTThe BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2.
The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2 in fingestick capillary blood and plasma samples.
Sponsors
Abbott Rapid Diagnostics Jena GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Operator of the device will be blinded to the outcome
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical performance of the BinaxNOW™ COVID-19 IgG Rapid Test | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Professional user usability | Through study completion, an average of 6 months | Evaluation of the usability of the BinaxNOW™ COVID-19 IgG Rapid Test Device when used by a Professional User |
| Self Test user usability | Through study completion, an average of 6 months | Evaluation of the usability of the BinaxNOW™ COVID-19 Antibody Self-Test when used by a lay person. |
| Matrix Equivalence Professional Use | Through study completion, an average of 6 months | Validation of the Matrix Equivalence between the Fingerstick Whole Blood and Plasma samples when used with the BinaxNOW COVID-19 IgG Rapid Test Device. |
| Diagnostic sensitivity and specificity | Through study completion, an average of 6 months | 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. |
Countries
United States
Outcome results
None listed