Nasal Swab Home Collection Kit (NSHC Kit) Study

NCT03813966 | Completed

• 3 other identifiers: 2018-1550A532050SMPH/FAMILY MEDICINE
• Study Type: observational
• Target: 1,181
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (2)

• Diagnostic specificity of self-collected to technician collected nasal swab samples

  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.

  1 day (Participant); 17 weeks (Study length)

• Diagnostic sensitivity of self-collected to technician collected nasal swab samples

  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 sensitivity 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.

  1 day (Participant); 17 weeks (Study length)

Interventions

Sofia Influenza A+B FIA DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A maximum of 1,000 patients, representing the random ages of the patients presenting at the Urgent Care facilities, will be enrolled.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Quidel Corporation: collaborator

Study Sites (2)

UWHealth Urgent Care Clinics

Madison, Wisconsin, 53704, United States

Location

UW Health Urgent Care Clinics

Madison, Wisconsin, 53717, United States

Location

Study Officials

• Jonathan Temte, MD PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 23, 2019
• Study Start: February 7, 2019
• Primary Completion: March 4, 2020
• Study Completion: June 30, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)