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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Exact Sciences

Madison, Wisconsin, 53719, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SARS-CoV-2

Diagnostic Test

Determine usability of study materials and kit

Primary outcomes

Valid SARS-CoV-2 Test

Time frame: 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)

Sponsors and collaborators

Lead sponsor

Exact Sciences Corporation

Industry

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: May 20, 2020
Registry last updated: Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed