N/A
N=30
Home Usability Study of the SARS-CoV-2 (COVID-19) Test
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04395391 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Valid SARS-CoV-2 Test — 30 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- SARS-CoV-2 (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Exact Sciences Corporation
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Valid SARS-CoV-2 Test |
30 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04395391). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.