Nasal Swab Home Collection Kit (NSHC Kit) Study

Status Completed

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03813966
Study type	Observational
Source	University of Wisconsin, Madison
Contact
Status	Completed
Phase
Start date	February 7, 2019
Completion date	June 30, 2020

View Details

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