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Nasal Swab Home Collection Kit (NSHC Kit) Study

NCT03813966 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1181

Last updated 2020-10-05

No results posted yet for this 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).

Conditions

  • Influenza Viral Infections

Interventions

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.

Sponsors & Collaborators

  • Quidel Corporation

    collaborator INDUSTRY

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Jonathan Temte, MD PhD · University of Wisconsin, Madison

Eligibility

Min Age
0 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-07
Primary Completion
2020-03-04
Completion
2020-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03813966 on ClinicalTrials.gov