<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/NCT03238274</url>
  </required_header>
  <id_info>
    <org_study_id>CS-0267-01</org_study_id>
    <nct_id>NCT03238274</nct_id>
  </id_info>
  <brief_title>Sofia 2 Lyme FIA Whole Blood Clinical Study</brief_title>
  <official_title>Sofia 2 Lyme FIA Whole Blood Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Quidel Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Quidel Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to demonstrate the clinical performance of the Sofia® 2&#xD;
      analyzer and Sofia Lyme FIA test in the CLIA waived test environment in comparison to&#xD;
      Comparator Method(s) and/or an FDA cleared predicate test(s) using matched finger-stick,&#xD;
      whole blood and serum from symptomatic subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to demonstrate the clinical performance of the Sofia® 2&#xD;
      analyzer and Sofia Lyme FIA test in the CLIA waived test environment in comparison to&#xD;
      Comparator Method(s) and/or an FDA cleared predicate test(s) using matched finger-stick,&#xD;
      whole blood and serum from symptomatic subjects. The finger-stick and venous whole blood&#xD;
      specimens will be tested by CLIA waived test operators. The matched plasma (from the leftover&#xD;
      whole blood) and serum specimens will be sent to a separate reference laboratory for testing&#xD;
      to compare the matched specimen using the Comparator Method(s) and/or an FDA-cleared&#xD;
      predicate test(s). The results of this study may be used to support a 510(k) and/or&#xD;
      CLIA-Waiver submission for testing whole blood sample types.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 6, 2017</start_date>
  <completion_date type="Actual">December 15, 2017</completion_date>
  <primary_completion_date type="Actual">December 15, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Detection of anti-B. burgdorferi IgG / IgM antibody</measure>
    <time_frame>15 minutes</time_frame>
    <description>Accurate detection of presence or absence of anti-B. burgdorferi IgG / IgM antibody</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">597</enrollment>
  <condition>Borrelia; Infection, Burgdorferi (Erythema Chronicum Migrans)</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <description>Arm 1 is a multi-site, single visit, prospective clinical study where subjects will be enrolled based on a physician's assessment of current Lyme specific symptoms from recent contact with a tick.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <description>Arm 2 will consist of subjects selected from a pool of patients that were previously determined to have Lyme disease either by the presence of the diagnostic rash (erythema migrans) or through laboratory findings and physician diagnosis based on patient symptoms. In this Arm the site may recruit by contacting subjects previously diagnosed with Lyme disease no longer than 16 months post diagnosis and no earlier than 1 week post diagnosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3</arm_group_label>
    <description>Arm 3 will consist of subjects selected from a pool of patients that were previously determined to have Lyme disease either by the presence of the diagnostic rash (erythema migrans) or through laboratory findings and physician diagnosis based on patient symptoms. In this Arm the site may recruit by contacting subjects previously diagnosed with Lyme disease between 17 months and 50 months post diagnosis. For the subject to be enrolled, a physician must have diagnosed the subject to have Lyme disease based on clinical symptoms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sofia 2 Lyme FIA testing</intervention_name>
    <description>IVD testing of whole blood or serum/plasma to aid in the detection of anti-B. burgdorferi IgG / IgM antibody</description>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_label>Arm 3</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Known or suspected exposure or tick-bite from an endemic area prior to onset of symptoms&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Arm 1 - Prospective symptomatic subjects, must have had a known or suspected exposure&#xD;
             or tick-bite from an endemic area prior to onset of symptoms, and be currently&#xD;
             exhibiting the following:&#xD;
&#xD;
          -  The physician determines that the subject has an expanding erythema migrans (EM)&#xD;
             lesion or &quot;bulls-eye rash&quot; with evidence of clearing in the center and has requested 2&#xD;
             tier serological testing or prescribed a ≥10 day course of antibiotics such as&#xD;
             doxycycline in subjects &gt; 8 years old or amoxicillin, cefuroxime or doxycycline in&#xD;
             subjects ≤8 years of age:&#xD;
&#xD;
        Or&#xD;
&#xD;
        - The physician must observe current symptoms, including:&#xD;
&#xD;
        At least three (3) of the listed acute stage symptoms listed:&#xD;
&#xD;
          -  fatigue&#xD;
&#xD;
          -  night sweats&#xD;
&#xD;
          -  chills&#xD;
&#xD;
          -  fever&#xD;
&#xD;
          -  headache&#xD;
&#xD;
          -  arthralgia&#xD;
&#xD;
          -  mildly stiff neck&#xD;
&#xD;
          -  myalgia i. one or more symptoms a. through h. are determined to be intermittent&#xD;
&#xD;
        Or,&#xD;
&#xD;
          -  at least one (1) of the following current conditions:&#xD;
&#xD;
          -  recurrent, brief attacks (weeks/months) of objective joint swelling in one or more&#xD;
             joints, sometimes followed by chronic arthritis in one or a few joints,&#xD;
&#xD;
          -  lymphocytic meningitis&#xD;
&#xD;
          -  cranial neuritis (partial facial palsy and may be bilateral)&#xD;
&#xD;
          -  radiculoneuropathy&#xD;
&#xD;
          -  encephalomyelitis&#xD;
&#xD;
          -  acute onset of high-grade (2nd or 3rd degree) atrioventricular conduction defects that&#xD;
             resolve in days to weeks, sometimes associated with myocarditis&#xD;
&#xD;
        In addition, the physician must be sufficiently confident in the possibility of Lyme&#xD;
        disease to have requested two-tier diagnostic testing and/or prescribed a ≥10 day course of&#xD;
        antibiotics such as doxycycline in patients &gt; 8 years old or amoxicillin, cefuroxime or&#xD;
        doxycycline in patients ≤8 years of age.&#xD;
&#xD;
        Arm 2 - Previously diagnosed with Lyme disease / confirmed case of Lyme disease: Within the&#xD;
        past 16 months, a physician must have previously diagnosed the subject based on the&#xD;
        presence of an EM rash or based on symptoms and confirmed by laboratory findings as&#xD;
        outlined in the CDC two Tier Testing algorithm. A copy of the subject's medical record&#xD;
        documenting the diagnosis must be obtained, and kept as source documentation at the&#xD;
        enrolling site.&#xD;
&#xD;
        Arm 3 - Previously diagnosed with Lyme disease / confirmed case of Lyme disease: Within the&#xD;
        past 17 to 50 months, a physician must have previously diagnosed the subject based on the&#xD;
        presence of an EM rash or based on symptoms and confirmed by laboratory findings as&#xD;
        outlined in the CDC two Tier Testing algorithm. A copy of the subject's medical record&#xD;
        documenting the diagnosis must be obtained, and kept as source documentation at the&#xD;
        enrolling site.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to understand and consent to participation; for minors this includes parent or&#xD;
             legal guardian.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tom Clement</last_name>
    <role>Study Director</role>
    <affiliation>Quidel Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NECCR Primacare Research, LLC</name>
      <address>
        <city>Fall River</city>
        <state>Massachusetts</state>
        <zip>02721</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Main Road Family Medicine</name>
      <address>
        <city>South Westport</city>
        <state>Massachusetts</state>
        <zip>02790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Essentia Institute of Rural Health</name>
      <address>
        <city>Duluth</city>
        <state>Minnesota</state>
        <zip>55805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Clinical Research</name>
      <address>
        <city>Endwell</city>
        <state>New York</state>
        <zip>13760</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altoona Center for Clinical Research</name>
      <address>
        <city>Duncansville</city>
        <state>Pennsylvania</state>
        <zip>16635</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harleysville Medical Associates</name>
      <address>
        <city>Harleysville</city>
        <state>Pennsylvania</state>
        <zip>19438</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lincoln Primary Care</name>
      <address>
        <city>Lincoln</city>
        <state>Rhode Island</state>
        <zip>02865</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Miriam Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Medical Research, LLC</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ocean State Primary Care</name>
      <address>
        <city>Westerly</city>
        <state>Rhode Island</state>
        <zip>02891</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Clinic Research Institute</name>
      <address>
        <city>Marshfield</city>
        <state>Wisconsin</state>
        <zip>54449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>March 16, 2018</last_update_submitted>
  <last_update_submitted_qc>March 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2018</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>Erythema Chronicum Migrans</mesh_term>
    <mesh_term>Borrelia Infections</mesh_term>
    <mesh_term>Erythema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan or intention to share participant data with others.</ipd_description>
  </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/NCT03238274
org study id: CS-0267-01
nct id: NCT03238274
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The objective of this study is to demonstrate the clinical performance of the Sofia® 2
      analyzer and Sofia Lyme FIA test in the CLIA waived test environment in comparison to
      Comparator Method(s) and/or an FDA cleared predicate test(s) using matched finger-stick,
      whole blood and serum from symptomatic subjects.
The objective of this study is to demonstrate the clinical performance of the Sofia® 2
      analyzer and Sofia Lyme FIA test in the CLIA waived test environment in comparison to
      Comparator Method(s) and/or an FDA cleared predicate test(s) using matched finger-stick,
      whole blood and serum from symptomatic subjects. The finger-stick and venous whole blood
      specimens will be tested by CLIA waived test operators. The matched plasma (from the leftover
      whole blood) and serum specimens will be sent to a separate reference laboratory for testing
      to compare the matched specimen using the Comparator Method(s) and/or an FDA-cleared
      predicate test(s). The results of this study may be used to support a 510(k) and/or
      CLIA-Waiver submission for testing whole blood sample types.
observational model: Cohort
time perspective: Prospective
measure: Detection of anti-B. burgdorferi IgG / IgM antibody
time frame: 15 minutes
description: Accurate detection of presence or absence of anti-B. burgdorferi IgG / IgM antibody
arm group label: Arm 1
description: Arm 1 is a multi-site, single visit, prospective clinical study where subjects will be enrolled based on a physician's assessment of current Lyme specific symptoms from recent contact with a tick.
arm group label: Arm 2
description: Arm 2 will consist of subjects selected from a pool of patients that were previously determined to have Lyme disease either by the presence of the diagnostic rash (erythema migrans) or through laboratory findings and physician diagnosis based on patient symptoms. In this Arm the site may recruit by contacting subjects previously diagnosed with Lyme disease no longer than 16 months post diagnosis and no earlier than 1 week post diagnosis.
arm group label: Arm 3
description: Arm 3 will consist of subjects selected from a pool of patients that were previously determined to have Lyme disease either by the presence of the diagnostic rash (erythema migrans) or through laboratory findings and physician diagnosis based on patient symptoms. In this Arm the site may recruit by contacting subjects previously diagnosed with Lyme disease between 17 months and 50 months post diagnosis. For the subject to be enrolled, a physician must have diagnosed the subject to have Lyme disease based on clinical symptoms.
intervention type: Device
intervention name: Sofia 2 Lyme FIA testing
description: IVD testing of whole blood or serum/plasma to aid in the detection of anti-B. burgdorferi IgG / IgM antibody
arm group label: Arm 1
arm group label: Arm 2
arm group label: Arm 3
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: N/A
healthy volunteers: No
last name: Tom Clement
role: Study Director
affiliation: Quidel Corporation
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Erythema Chronicum Migrans
mesh term: Borrelia Infections
mesh term: Erythema
sharing ipd: No
ipd description: There is no plan or intention to share participant data with others.