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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-18

Study Completion Date

2020-06-16

Brief Summary

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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

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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.

Conditions

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COVID-19

Keywords

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COVID-19 Sample Collection Human Factors Study Nasal Swab

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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SARS-CoV-2

Determine usability of study materials and kit

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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Exact Sciences

Madison, Wisconsin, United States

Site Status

Countries

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United States

Provided Documents

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Other Identifiers

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2020-06

Identifier Type: -

Identifier Source: org_study_id