Nasal Swab Home Collection Kit (NSHC Kit) Study

Influenza Viral Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03813966
• Other study ID #: 2018-1550
• Secondary ID: A532050SMPH/FAMI
• Status: Completed
• Start date: February 7, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: October 2020
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1181
• Est. completion date: June 30, 2020
• Est. primary completion date: March 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Influenza Viral Infections
• Influenza, Human
• Virus Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	UW Health Urgent Care Clinics	Madison	Wisconsin
United States	UWHealth Urgent Care Clinics	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Quidel Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)