Nasal Swab Home Collection Kit (NSHC Kit) Study

University of Wisconsin (UW)

Status: Completed

Conditions: Influenza Viral Infections

Treatments: Diagnostic Test: Sofia Influenza A+B FIA

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03813966

A532050 (Other Identifier)

SMPH/FAMILY MEDICINE (Other Identifier)

2018-1550

Details and patient eligibility

About

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).

Enrollment: 1,181 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Fever
• Nasal Congestion
• Rhinorrhea
• Sore Throat
• Cough

Exclusion criteria

• Unable to read and understand or refusal to sign the appropriate informed consent/assent forms
• Refusal to complete the patient's demographic and medical history
• Treatment with anti-influenza antivirals within the previous 7 days
• Vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.