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NCT04447495 · ClinicalTrials.gov registry record
Self-sampling for the Study of COVID-19
A clinical trial, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- 126
- Enrollment target
NCT04447495: Completed study, sponsored by Medical College of Wisconsin.
NCT04447495 is a clinical trial that has completed, run by Medical College of Wisconsin. The registered enrollment target is 126 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04447495 has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- 126 participants
- Enrollment target
Study Summary
This study will evaluate the feasibility of self-sampling with the iAMP® COVID-19 Detection Kit (Atila BioSystems, Mountain View, CA), a new, low-cost SARS-CoV-2 test that does not require RNA extraction. The investigators will compare the sensitivity and specificity of the iAMP® assay on self-sampled mid-turbinate, anterior nares, and saliva swabs against the gold standard, a nucleic acid amplification testing assay on a clinician-collected nasopharyngeal swab.
Primary Outcome
Validate the iAMP® testing kit for use in the mid-turbinate, anterior nares and with saliva collection and compare the sensitivities and specificities of each site to nasopharyngeal collection.
Interventions
- DIAGNOSTIC_TEST iAMP test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2020-12-31 |
What the finished NCT04447495 record still lists
NCT04447495 is an observational study that tracks outcomes without assigning an intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which iAMP test is the first listed.
NCT04447495 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04447495 about?
NCT04447495 is a clinical study titled "Self-sampling for the Study of COVID-19". This study will evaluate the feasibility of self-sampling with the iAMP® COVID-19 Detection Kit (Atila BioSystems, Mountain View, CA), a new, low-cost SARS-CoV-2 test that does not require RNA extraction. The investigators will compare the sensitivity and specificity of the iAMP® assay on self-sampl...
What is the current status of trial NCT04447495?
This trial is currently completed. The enrollment target is 126 participants. The study started on 2020-07-01. Estimated completion is 2020-12-31.
What interventions are being tested in trial NCT04447495?
The interventions under investigation include: iAMP test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04447495?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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