Trials / Completed
CompletedNCT04395391
Home Usability Study of the SARS-CoV-2 (COVID-19) Test
Usability Study of Home Collection and Mailing With SARS-CoV-2 Test Specimen Collection Materials (2020-06)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (actual)
- Sponsor
- Exact Sciences Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The primary objective is to determine the usability of the SARS-CoV-2 Specimen Collection Materials for at-home collection and mailing of sample to the testing laboratory.
Detailed description
This study is a prospective observational human factors usability study designed to evaluate the Instructions For Use (IFU) in the SARS-CoV-2 Specimen Collection Materials based on the successful completion of self-collection of a nasal swab sample, which includes a valid SARS-CoV-2 test result.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | SARS-CoV-2 | Determine usability of study materials and kit |
Timeline
- Start date
- 2020-05-18
- Primary completion
- 2020-05-21
- Completion
- 2020-06-16
- First posted
- 2020-05-20
- Last updated
- 2023-12-13
- Results posted
- 2023-12-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04395391. Inclusion in this directory is not an endorsement.