Official Title
Usability Study of Home Collection and Mailing With SARS-CoV-2 Test Specimen Collection Materials (2020-06)
Brief 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.

Status
Completed
Conditions
COVID-19
Interventions

Diagnostic Test: SARS-CoV-2

Determine usability of study materials and kit

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Exact Sciences
Madison, Wisconsin, United States

Sponsors / Collaborators
Exact Sciences Corporation
NCT Number
NCT04395391
Keywords
Covid-19
Sample Collection
Human Factors Study
Nasal Swab
MeSH Terms
COVID-19