Home Usability Study of the SARS-CoV-2 (COVID-19) Test
Purpose
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.
Condition
- COVID-19
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Ability to provide informed consent
Exclusion Criteria
- Prior medical or laboratory training - Prior experience with COVID-19 specimen self-collection - Prior SARS-CoV-2 testing
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
More Details
- NCT ID
- NCT04395391
- Status
- Completed
- Sponsor
- Exact Sciences Corporation
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.