Trials / Completed
CompletedNCT04959760
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 263 (actual)
- Sponsor
- Abbott Rapid Diagnostics Jena GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | The 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. |
Timeline
- Start date
- 2021-06-03
- Primary completion
- 2022-01-20
- Completion
- 2022-01-20
- First posted
- 2021-07-13
- Last updated
- 2022-05-09
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04959760. Inclusion in this directory is not an endorsement.