<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/NCT04401631</url>
  </required_header>
  <id_info>
    <org_study_id>AB-ALL-3.1</org_study_id>
    <nct_id>NCT04401631</nct_id>
  </id_info>
  <brief_title>Analytical Validation of the abioSCOPE Device With an IgE Test Panel: Point-of-Care Precision, Sample Type Comparison and Method Correlation</brief_title>
  <official_title>Analytical Validation of the abioSCOPE Device With an IgE Test Panel: Point-of-Care Precision, Sample Type Comparison and Method Correlation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abionic SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NAMSA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Abionic SA</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, prospective, observational study to evaluate the analytical&#xD;
      performance of the Abionic IgE Multi-Allergen Test Panel on the abioSCOPE® device in a U.S.&#xD;
      point-of-care environment within a clinical laboratory operating under a CLIA certificate for&#xD;
      tests of moderate complexity. The study will assess point-of-care ('external') precision,&#xD;
      sample type comparison and correlation with a reference method (Phadia Laboratory System,&#xD;
      ThermoFisher Scientific).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Sponsor financial has been stopped&#xD;
  </why_stopped>
  <start_date type="Anticipated">November 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">November 2020</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>POC variance components (in a POL environment):</measure>
    <time_frame>Day 1</time_frame>
    <description>External Precision Study ('reproducibility study' 'site-to-site precision study'): Demonstrate that the imprecision of K3-EDTA venous plasma using the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device (all 5 allergens/allergen mixes and total IgE) in the hands of trained Healthcare Professionals in a Physician Office Laboratory (POL) is within the expected range of the imprecision established in the clinical laboratory by Laboratory Scientists.&#xD;
Operator-to-Operator imprecision on whole blood: Demonstrate that the between-Operator reproducibility of the total IgE of the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device test results is within the expected range of variability.&#xD;
Between-run reproducibility: Demonstrate that the between-run reproducibility of venous whole blood samples measured with the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device (all 5 allergens/allergen mixes and total IgE) is within the expected range of variability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sample type comparison:</measure>
    <time_frame>Day 1</time_frame>
    <description>Demonstrate that the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device test results obtained from capillary whole blood correlates well with values obtained from K3-EDTA anticoagulated venous plasma and serum samples.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Method comparison</measure>
    <time_frame>Day 1</time_frame>
    <description>Demonstrate that test results obtained with the total IgE test of the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device correlates with total IgE test results from the reference method (Phadia Laboratory System, ThermoFisher Scientific).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Allergy</condition>
  <condition>Allergic Asthma</condition>
  <condition>Allergy to Cats</condition>
  <condition>Allergy to House Dust</condition>
  <condition>Allergy to Dog Dander (Finding)</condition>
  <condition>Allergy Mold</condition>
  <condition>Allergy Cockroach</condition>
  <arm_group>
    <arm_group_label>Interventions</arm_group_label>
    <description>A minimum of 20 subjects with targeted levels of total IgE are needed to participate in the Operator-to-Operator whole blood study.&#xD;
A minimum of 20 subjects with targeted levels of allergen-specific and total IgE are needed to participate in the capillary whole blood between-run imprecision study in the POL environment.&#xD;
A minimum of 40 subjects with targeted levels of Fel d 1-specific IgE and total IgE are needed to participate in the sample type comparison study. These subjects will be recruited, and their samples analyzed at 1 POL.&#xD;
A minimum of 300 subjects (approximately 100 subjects enrolled and evaluated at each of three sites) and with targeted levels of total IgE are needed to participate in the method comparison study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Blood Collection</intervention_name>
    <description>Between-Run Reproducibility K3-EDTA venous whole blood 3 mL 1 venous draw&#xD;
Operator-to-operator imprecision (abioSCOPE) K3-EDTA capillary whole blood 0.05 mL/draw; 0.15 mL total 3 finger sticks (3 different fingers)&#xD;
Sample type comparison (abioSCOPE) K3-EDTA capillary whole blood, venous serum, venous K3-EDTA plasma 0.35 mL (finger stick), 9 mL of whole blood to get a minimum of 3 mL of serum and 9 mL of whole blood K3-EDTA to get a minimum of 3 mL of plasma 1 finger stick; 1 venous draw into serum tube (9 mL) and 1 venous draw into K3-EDTA plasma tube (9 mL), in total 18 mL&#xD;
Method comparison (abioSCOPE and ImmunoCAP/Phadia) K3-EDTA capillary whole blood, venous K3-EDTA plasma 0.05 mL (finger stick), 9 mL of whole blood to get a minimum of 3 ml of plasma 1 finger stick; 1 venous draw into K3-EDTA plasma tube (9 mL tube)</description>
    <arm_group_label>Interventions</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        -  A minimum of 20 subjects with targeted levels of total IgE are needed to participate&#xD;
             in the Operator-to-Operator whole blood study.&#xD;
&#xD;
          -  A minimum of 20 subjects with targeted levels of allergen-specific and total IgE are&#xD;
             needed to participate in the capillary whole blood between-run imprecision study in&#xD;
             the POL environment.&#xD;
&#xD;
          -  A minimum of 40 subjects with targeted levels of Fel d 1-specific IgE and total IgE&#xD;
             are needed to participate in the sample type comparison study. These subjects will be&#xD;
             recruited, and their samples analyzed at 1 POL.&#xD;
&#xD;
          -  A minimum of 300 subjects (approximately 100 subjects enrolled and evaluated at each&#xD;
             of three sites) and with targeted levels of total IgE are needed to participate in the&#xD;
             method comparison study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provision and understanding of signed and dated written informed consent by the&#xD;
             subject prior to any mandatory study-specific procedures, sample collection, or&#xD;
             analysis.&#xD;
&#xD;
          -  Male or female, 18 years of age or older.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject participating in another study that may influence test results.&#xD;
&#xD;
          -  Subject taking any of the following medications: systemic steroids (inhaled or nasal&#xD;
             steroids are allowed), anti-cytokines or cytokines, systemic interferon (injection&#xD;
             local interferon α for the treatment of HPV is allowed), anti-IgE therapy (approved or&#xD;
             investigational) or treated with systemic chemotherapy.&#xD;
&#xD;
          -  History of cancer, autoimmune, or immune deficiency disease.&#xD;
&#xD;
          -  Suffering from a hematological pathology (coagulation disorder, severe anemia) that&#xD;
             could interfere with the blood draw procedure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>George Washington University, Washington DC</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University, Baltimore</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Bernstein Clinical Research Center Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45231</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>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</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>
  <keyword>Allergy</keyword>
  <keyword>Asthma</keyword>
  <keyword>Point-of-Care</keyword>
  <keyword>Immunoassay</keyword>
  <keyword>In vitro Diagnostic</keyword>
  <keyword>Total IgE</keyword>
  <keyword>Specific allergy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04401631
org study id: AB-ALL-3.1
nct id: NCT04401631
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
This is a multicenter, prospective, observational study to evaluate the analytical
      performance of the Abionic IgE Multi-Allergen Test Panel on the abioSCOPE® device in a U.S.
      point-of-care environment within a clinical laboratory operating under a CLIA certificate for
      tests of moderate complexity. The study will assess point-of-care ('external') precision,
      sample type comparison and correlation with a reference method (Phadia Laboratory System,
      ThermoFisher Scientific).
observational model: Cohort
time perspective: Prospective
measure: POC variance components (in a POL environment):
time frame: Day 1
description: External Precision Study ('reproducibility study' 'site-to-site precision study'): Demonstrate that the imprecision of K3-EDTA venous plasma using the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device (all 5 allergens/allergen mixes and total IgE) in the hands of trained Healthcare Professionals in a Physician Office Laboratory (POL) is within the expected range of the imprecision established in the clinical laboratory by Laboratory Scientists.
Operator-to-Operator imprecision on whole blood: Demonstrate that the between-Operator reproducibility of the total IgE of the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device test results is within the expected range of variability.
Between-run reproducibility: Demonstrate that the between-run reproducibility of venous whole blood samples measured with the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device (all 5 allergens/allergen mixes and total IgE) is within the expected range of variability.
measure: Sample type comparison:
time frame: Day 1
description: Demonstrate that the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device test results obtained from capillary whole blood correlates well with values obtained from K3-EDTA anticoagulated venous plasma and serum samples.
measure: Method comparison
time frame: Day 1
description: Demonstrate that test results obtained with the total IgE test of the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device correlates with total IgE test results from the reference method (Phadia Laboratory System, ThermoFisher Scientific).
arm group label: Interventions
description: A minimum of 20 subjects with targeted levels of total IgE are needed to participate in the Operator-to-Operator whole blood study.
A minimum of 20 subjects with targeted levels of allergen-specific and total IgE are needed to participate in the capillary whole blood between-run imprecision study in the POL environment.
A minimum of 40 subjects with targeted levels of Fel d 1-specific IgE and total IgE are needed to participate in the sample type comparison study. These subjects will be recruited, and their samples analyzed at 1 POL.
A minimum of 300 subjects (approximately 100 subjects enrolled and evaluated at each of three sites) and with targeted levels of total IgE are needed to participate in the method comparison study.
intervention type: Device
intervention name: Blood Collection
description: Between-Run Reproducibility K3-EDTA venous whole blood 3 mL 1 venous draw
Operator-to-operator imprecision (abioSCOPE) K3-EDTA capillary whole blood 0.05 mL/draw; 0.15 mL total 3 finger sticks (3 different fingers)
Sample type comparison (abioSCOPE) K3-EDTA capillary whole blood, venous serum, venous K3-EDTA plasma 0.35 mL (finger stick), 9 mL of whole blood to get a minimum of 3 mL of serum and 9 mL of whole blood K3-EDTA to get a minimum of 3 mL of plasma 1 finger stick; 1 venous draw into serum tube (9 mL) and 1 venous draw into K3-EDTA plasma tube (9 mL), in total 18 mL
Method comparison (abioSCOPE and ImmunoCAP/Phadia) K3-EDTA capillary whole blood, venous K3-EDTA plasma 0.05 mL (finger stick), 9 mL of whole blood to get a minimum of 3 ml of plasma 1 finger stick; 1 venous draw into K3-EDTA plasma tube (9 mL tube)
arm group label: Interventions
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypersensitivity
sharing ipd: Undecided