NCT03813966|Completed
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
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Self- and Parent/Guardian-Collection of Specimens for Rapid Influenza Nasal Swab Home Collection Kit (NSHC Kit) Study
Sponsor study identifier
Secondary identifiers
OTHER · UW Madison
OTHER · UW Madison
observational
1,181
1 country
2
Study Start
February 7, 2019
Actual (reported)Primary Completion
March 4, 2020
Actual (reported)Study Completion
June 30, 2020
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2020
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 15, 2019
Actual (reported)January 23, 2019
Actual (reported)February 7, 2019
Actual (reported)March 4, 2020
Actual (reported)June 30, 2020
Actual (reported)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)
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
A maximum of 1,000 patients, representing the random ages of the patients presenting at the Urgent Care facilities, will be enrolled.
UWHealth Urgent Care Clinics
Madison, Wisconsin, 53704, United States
UW Health Urgent Care Clinics
Madison, Wisconsin, 53717, United States
Jonathan Temte, MD PhD
University of Wisconsin, Madison
1,181 participants (actual enrollment reported by the registry).
First Submitted
January 15, 2019
First Posted
January 23, 2019
Study Start
February 7, 2019
Actual (reported)Intradermal Influenza Vaccine in the Young
Contact the study team to confirm eligibility.
Primary Completion
March 4, 2020
Actual (reported)Study Completion
June 30, 2020
Actual (reported)Last Updated
October 5, 2020
Record last verified: 2020-10
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Source: ClinicalTrials.gov.
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