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NCT04395391 Clinical Trial

Home Usability Study of the SARS-CoV-2 (COVID-19) Test

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04395391
Other study ID # 2020-06
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 18, 2020
Est. completion date June 16, 2020

Study information
Verified date December 2023
Source Exact Sciences Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date June 16, 2020
Est. primary completion date May 21, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• SARS-CoV-2
Determine usability of study materials and kit

Locations
Country Name City State
United States Exact Sciences Madison Wisconsin

Sponsors (1)
Lead Sponsor Collaborator
Exact Sciences Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Valid SARS-CoV-2 Test The percent of samples from the fully enrolled cohort to return a valid SARS-CoV-2 test result (positive, not detected, or inconclusive) Subjects are assessed at enrollment
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