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.
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 Type
OBSERVATIONAL
Enrollment
30
Determine usability of study materials and kit
Exact Sciences
Madison, Wisconsin, United States
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)
Time frame: Subjects are assessed at enrollment
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