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

Exact Sciences Corporation

Status: Completed

Conditions: COVID-19

Treatments: Diagnostic Test: SARS-CoV-2

Study type: Observational

Funder types: Industry

Identifiers

NCT04395391

2020-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design