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).

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Key information

Conditions

Influenza Viral Infections

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UW Health Urgent Care Clinics, Madison, Wisconsin, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

Time frame: 1 day (Participant); 17 weeks (Study length)

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

Time frame: 1 day (Participant); 17 weeks (Study length)

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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

Quidel Corporation

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Jan 23, 2019
Registry last updated: Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed