<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/NCT03012217</url>
  </required_header>
  <id_info>
    <org_study_id>DX-SDY-026541</org_study_id>
    <nct_id>NCT03012217</nct_id>
  </id_info>
  <brief_title>Prospective Clinical Evaluation of the FilmArray Respiratory Panel 2</brief_title>
  <acronym>RP2</acronym>
  <official_title>Prospective Clinical Evaluation of the FilmArray Respiratory Panel 2 (RP2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioFire Diagnostics, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BioFire Diagnostics, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a performance study to test the sensitivity and specificity of the BioFire FilmArray&#xD;
      Respiratory Panel (RP) 2. The purpose of this study is to prospectively collect and test&#xD;
      residual NPS specimens and generate performance data to support regulatory classification of&#xD;
      the FilmArray RP2 as an in vitro diagnostic (IVD) in the US, European Union (EU), Canada, and&#xD;
      other regions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The FilmArray Respiratory Panel 2 (RP2) is an automated sample-to-answer PCR-based diagnostic&#xD;
      for the identification of common upper respiratory viral and bacterial pathogens in&#xD;
      nasopharyngeal swab (NPS) specimens collected in viral transport media (VTM). The purpose of&#xD;
      this study is to prospectively collect and test residual NPS specimens and generate&#xD;
      performance data to support regulatory classification of the FilmArray RP2 as an in vitro&#xD;
      diagnostic (IVD) in the US, European Union (EU), Canada, and other regions.&#xD;
&#xD;
      Clinical performance evaluations will be initiated at sites in the US and/or EU during the&#xD;
      2016/2017 respiratory illness season, approximately September through December.Prior to&#xD;
      performing the prospective clinical evaluation, each participating site will have the&#xD;
      necessary Institutional Review Board (IRB) reviews (or equivalent for non-U.S. sites).&#xD;
&#xD;
      Specimens for inclusion in this study will be residual, de-identified NPS collected in VTM&#xD;
      leftover from clinician-ordered respiratory pathogen testing.&#xD;
&#xD;
      Comparator testing will be performed using de-identified specimen aliquots at a central&#xD;
      reference laboratory.&#xD;
&#xD;
      This study is funded by BioFire Diagnostics, LLC. The FilmArray device conforms to the&#xD;
      requirements of the European Union In Vitro Diagnostic Directive (IVDD). This study was&#xD;
      designed such that every precaution has been taken to protect the health and safety of&#xD;
      patients, users, and other persons.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>sensitivity and specificity of device</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1612</enrollment>
  <condition>Upper Resp Tract Infection</condition>
  <arm_group>
    <arm_group_label>Specimens that meet inclusion criteria</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational Study</intervention_name>
    <arm_group_label>Specimens that meet inclusion criteria</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Nasopharyngeal swabs.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Only residual NPS specimens from patients with clinician-ordered respiratory pathogen&#xD;
        testing will be enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Specimen is residual NPS in VTM left over from standard of care testing under&#xD;
             clinician order for respiratory pathogen analysis&#xD;
&#xD;
          -  Specimen has been held at appropriate temperature&#xD;
&#xD;
          -  Sufficient volume remaining after standard of care testing and available for use in&#xD;
             the study&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Specimen other than NPS in VTM (e.g. nasopharyngeal aspirate, anterior or midturbinate&#xD;
             swab, oropharyngeal swab, NPS collected in medium other than VTM)&#xD;
&#xD;
          -  Specimen cannot be tested within the defined storage parameters&#xD;
&#xD;
          -  Insufficient specimen volume for testing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primary Children's Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2017</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>Respiratory Tract Infections</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/NCT03012217
org study id: DX-SDY-026541
nct id: NCT03012217
lead sponsor: 
has dmc: No
This is a performance study to test the sensitivity and specificity of the BioFire FilmArray
      Respiratory Panel (RP) 2. The purpose of this study is to prospectively collect and test
      residual NPS specimens and generate performance data to support regulatory classification of
      the FilmArray RP2 as an in vitro diagnostic (IVD) in the US, European Union (EU), Canada, and
      other regions.
The FilmArray Respiratory Panel 2 (RP2) is an automated sample-to-answer PCR-based diagnostic
      for the identification of common upper respiratory viral and bacterial pathogens in
      nasopharyngeal swab (NPS) specimens collected in viral transport media (VTM). The purpose of
      this study is to prospectively collect and test residual NPS specimens and generate
      performance data to support regulatory classification of the FilmArray RP2 as an in vitro
      diagnostic (IVD) in the US, European Union (EU), Canada, and other regions.

      Clinical performance evaluations will be initiated at sites in the US and/or EU during the
      2016/2017 respiratory illness season, approximately September through December.Prior to
      performing the prospective clinical evaluation, each participating site will have the
      necessary Institutional Review Board (IRB) reviews (or equivalent for non-U.S. sites).

      Specimens for inclusion in this study will be residual, de-identified NPS collected in VTM
      leftover from clinician-ordered respiratory pathogen testing.

      Comparator testing will be performed using de-identified specimen aliquots at a central
      reference laboratory.

      This study is funded by BioFire Diagnostics, LLC. The FilmArray device conforms to the
      requirements of the European Union In Vitro Diagnostic Directive (IVDD). This study was
      designed such that every precaution has been taken to protect the health and safety of
      patients, users, and other persons.
observational model: Case-Only
time perspective: Prospective
measure: sensitivity and specificity of device
time frame: 3 months
arm group label: Specimens that meet inclusion criteria
intervention type: Other
intervention name: Observational Study
arm group label: Specimens that meet inclusion criteria
Nasopharyngeal swabs.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Respiratory Tract Infections
sharing ipd: No