Trials / Completed
CompletedNCT05080231
COVID-19 Immunity Assessment
Blood Specimen Collection for COVID-19 Immunity Assessment Mailer Kit Clinical Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 662 (actual)
- Sponsor
- DxTerity Diagnostics · Industry
- Sex
- All
- Age
- 13 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to collect blood specimens from individuals post infection or post vaccination over time to assess COVID19 Immunity.
Detailed description
The DxTerity COVID-19 Immunity Assessment Collection Mailer Kit contains the DxCollect MicroCollection Device (MCD) Serology fingerstick blood collection device packaged as a home collection kit, designed for collection and shipment of fingerstick blood back to DxTerity CLIA (Clinical Laboratory Improvements Amendment) certified laboratory for testing. The clinical performance of the collection device for use with anti-SARS-CoV-2 antibody tests will be evaluated for use with cPASS™ anti-SARS-CoV-2 neutralizing antibody detection kit (EUA 201427). The samples may also be used for assessing immunity or protection post COVID-19 vaccination.
Conditions
Timeline
- Start date
- 2021-07-15
- Primary completion
- 2021-09-10
- Completion
- 2021-09-10
- First posted
- 2021-10-15
- Last updated
- 2023-08-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05080231. Inclusion in this directory is not an endorsement.