<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03813966</url>
  </required_header>
  <id_info>
    <org_study_id>2018-1550</org_study_id>
    <secondary_id>A532050</secondary_id>
    <secondary_id>SMPH/FAMILY MEDICINE</secondary_id>
    <nct_id>NCT03813966</nct_id>
  </id_info>
  <brief_title>Nasal Swab Home Collection Kit (NSHC Kit) Study</brief_title>
  <official_title>Self- and Parent/Guardian-Collection of Specimens for Rapid Influenza Nasal Swab Home Collection Kit (NSHC Kit) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Quidel Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to demonstrate that persons over the age of 13 years can obtain&#xD;
      a self-collected nasal swab reliably and safely for subsequent use in the diagnosis of&#xD;
      influenza. Similarly, the purpose is to demonstrate that parents or guardians can safely and&#xD;
      effectively collect nasal swab specimens from children, ages 0 through 12 years, and others&#xD;
      needing assistance in doing so, and that these parent/guardian-collected nasal swabs can also&#xD;
      be used in the diagnosis of influenza. Clinical performance of the swabs will be based on the&#xD;
      comparison of the performance of the nasal swab that is self- or parent/guardian-collected to&#xD;
      one collected from the same specimen donor by a skilled clinical coordinator and used in CLIA&#xD;
      (Clinical Laboratory Improvement Amendments)-waived, rapid diagnostic test called Sofia&#xD;
      Influenza A+B FIA (fluorescence immunoassay analyzer).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 7, 2019</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">March 4, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic specificity of self-collected to technician collected nasal swab samples</measure>
    <time_frame>1 day (Participant); 17 weeks (Study length)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnostic sensitivity of self-collected to technician collected nasal swab samples</measure>
    <time_frame>1 day (Participant); 17 weeks (Study length)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <enrollment type="Actual">1181</enrollment>
  <condition>Influenza Viral Infections</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Sofia Influenza A+B FIA</intervention_name>
    <description>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.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A maximum of 1,000 patients, representing the random ages of the patients presenting at the&#xD;
        Urgent Care facilities, will be enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fever&#xD;
&#xD;
          -  Nasal Congestion&#xD;
&#xD;
          -  Rhinorrhea&#xD;
&#xD;
          -  Sore Throat&#xD;
&#xD;
          -  Cough&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to read and understand or refusal to sign the appropriate informed&#xD;
             consent/assent forms&#xD;
&#xD;
          -  Refusal to complete the patient's demographic and medical history&#xD;
&#xD;
          -  Treatment with anti-influenza antivirals within the previous 7 days&#xD;
&#xD;
          -  Vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7&#xD;
             days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan Temte, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UWHealth Urgent Care Clinics</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UW Health Urgent Care Clinics</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53717</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>October 1, 2020</last_update_submitted>
  <last_update_submitted_qc>October 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
    <mesh_term>Virus Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03813966
org study id: 2018-1550
secondary id: A532050
secondary id: SMPH/FAMILY MEDICINE
nct id: NCT03813966
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
observational model: Case-Only
time perspective: Prospective
measure: Diagnostic specificity of self-collected to technician collected nasal swab samples
time frame: 1 day (Participant); 17 weeks (Study length)
description: 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.
measure: Diagnostic sensitivity of self-collected to technician collected nasal swab samples
time frame: 1 day (Participant); 17 weeks (Study length)
description: 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.
intervention type: Diagnostic Test
intervention name: Sofia Influenza A+B FIA
description: 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.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 0 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jonathan Temte, MD PhD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Virus Diseases
sharing ipd: No