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

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).

Study Overview

• Status: Completed
• Conditions: Influenza Viral Infections
• Intervention / Treatment: Diagnostic test: Sofia Influenza A+B FIA

• Study Type: Observational
• Enrollment (Actual): 1181

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • UWHealth Urgent Care Clinics
    • Madison, Wisconsin, United States, 53717
      • UW Health Urgent Care Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Quidel Corporation
• Investigators: Principal Investigator: Jonathan Temte, MD PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2019
• Primary Completion (Actual): March 4, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: January 15, 2019
• First Submitted That Met QC Criteria: January 22, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: October 1, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Virus Diseases; Influenza, Human
• Other Study ID Numbers: 2018-1550; A532050 (Other Identifier: UW Madison); SMPH/FAMILY MEDICINE (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No