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NCT03813966 · ClinicalTrials.gov registry record
Nasal Swab Home Collection Kit (NSHC Kit) Study
A clinical trial of Influenza Viral Infections, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- 1,181
- Enrollment target
- 2
- Study locations
NCT03813966: Completed study of Influenza Viral Infections, sponsored by University of Wisconsin, Madison.
NCT03813966 is a study of Influenza Viral Infections that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 1,181 participants. The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03813966, a study of Influenza Viral Infections, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- 1,181 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to demonstrate that persons over the age of 13 years can obtain a self-collected nasal swab reliably and safely for subsequent use in the diagnosis of influenza. Similarly, the purpose is to demonstrate that parents or guardians can safely and effectively collect nasal swab specimens from children, ages 0 through 12 years, and others needing assistance in doing so, and that these parent/guardian-collected nasal swabs can also be used in the diagnosis of influenza. Clinical performance of the swabs will be based on the comparison of the performance of the nasal swab that is self- or parent/guardian-collected to one collected from the same specimen donor by a skilled clinical coordinator and used in CLIA (Clinical Laboratory Improvement Amendments)-waived, rapid diagnostic test called Sofia Influenza A+B FIA (fluorescence immunoassay analyzer).
Primary Outcome
Hypothesis tested is that self-collected nasal swab are as accurate as nasal swabs collected by a trained healthcare worker for the diagnosis of influenza by CLIA-waived, rapid diagnostic test called Quidel Sofia Influenza A+B Fluorescent Immunoassay. The investigators will specifically measure the specificity of self-collected specimens as compared to the clinical standard (trained healthcare worker collected specimen), estimating it using standard methods along with 95th% confidence intervals.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Sofia Influenza A+B FIA
Study Locations (2)
Wisconsin
- UWHealth Urgent Care Clinics - Madison
- UW Health Urgent Care Clinics - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,181 participants |
| Start Date | 2019-02-07 |
| Est. Completion | 2020-06-30 |
What the finished NCT03813966 record still lists
NCT03813966 is an observational study that tracks outcomes without assigning an intervention. Its 1,181 participants enrollment target places it among the larger protocols in the corpus.
The record links to 1 condition, with Influenza Viral Infections appearing as the primary indexed condition, and to 1 intervention - of which Sofia Influenza A+B FIA is the first listed.
NCT03813966 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT03813966 about?
NCT03813966 is a clinical study titled "Nasal Swab Home Collection Kit (NSHC Kit) Study". The purpose of this study is to demonstrate that persons over the age of 13 years can obtain a self-collected nasal swab reliably and safely for subsequent use in the diagnosis of influenza. Similarly, the purpose is to demonstrate that parents or guardians can safely and effectively collect nasal s...
What is the current status of trial NCT03813966?
This trial is currently completed. The enrollment target is 1,181 participants. The study started on 2019-02-07. Estimated completion is 2020-06-30.
What conditions does trial NCT03813966 study?
This clinical trial studies the following conditions: Influenza Viral Infections.
What interventions are being tested in trial NCT03813966?
The interventions under investigation include: Sofia Influenza A+B FIA (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03813966?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03813966 being conducted?
This trial has 2 study locations across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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