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

Completed

• Conditions: COVID-19

• Registration Number: NCT04395391
• Lead Sponsor: Exact Sciences Corporation

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.

Study Timeline

• Study Start: 2020-05-18
• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-19
• Study First Posted: 2020-05-20
• Primary Completion: 2020-05-21
• Study Completion: 2020-06-16
• Results First Submitted: 2022-12-27
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-11
• Last Update Submitted: 2023-12-11
• Results First Posted: 2023-12-13
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Valid SARS-CoV-2 Test	Subjects are assessed at enrollment	The percent of samples from the fully enrolled cohort to return a valid SARS-CoV-2 test result (positive, not detected, or inconclusive)

Trial Locations

Locations (1)

Exact Sciences; 🇺🇸 Madison, Wisconsin, United States