NCT03813966

Nasal Swab Home Collection Kit (NSHC Kit) Study

Self- and Parent/Guardian-Collection of Specimens for Rapid Influenza Nasal Swab Home Collection Kit (NSHC Kit) Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,181 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 0 Years
• Healthy volunteers: Accepted

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).

Conditions

• Influenza Viral Infections

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Sofia Influenza A+B FIA	The Nasal Swab Home Collection Kit (NSHC Kit) provides the materials and training needed for you to safely collect a nasal swab at home. The sample can then be delivered to a designated test site for influenza testing.

Timeline

• Start date: 2019-02-07
• Primary completion: 2020-03-04
• Completion: 2020-06-30
• First posted: 2019-01-23
• Last updated: 2020-10-05

Locations

2 sites across 1 country: United States