<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/NCT03248960</url>
  </required_header>
  <id_info>
    <org_study_id>iE-FLU-AUS-1701</org_study_id>
    <nct_id>NCT03248960</nct_id>
  </id_info>
  <brief_title>Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.</brief_title>
  <official_title>A Prospective Multi-Centre Study of the Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ellume Pty Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ellume Pty Ltd</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to validate the sensitivity and specificity of the&#xD;
      iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B&#xD;
      as compared to viral culture.&#xD;
&#xD;
      The secondary aims are to:&#xD;
&#xD;
      Validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu&#xD;
      A+B Test in detecting influenza A and influenza B as compared to Reverse Transcriptase&#xD;
      Polymerase Chain Reaction (RT-PCR).&#xD;
&#xD;
      Evaluate the correct interpretation of the iTreat Flu A+B Test by subjects with&#xD;
      influenza-like symptoms.&#xD;
&#xD;
      Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the&#xD;
      iTreat Flu A+B Test.&#xD;
&#xD;
      Evaluate the operators' satisfaction with the ease of use of the ellume.lab Flu A+B Test.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 27, 2017</start_date>
  <completion_date type="Actual">December 23, 2017</completion_date>
  <primary_completion_date type="Actual">December 23, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by iTreat Flu A+B Test.</measure>
    <time_frame>1 day</time_frame>
    <description>Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by ellume.lab Flu A+B Test.</measure>
    <time_frame>1 day</time_frame>
    <description>Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by iTreat Flu A+B Test.</measure>
    <time_frame>1 day</time_frame>
    <description>Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by ellume.lab Flu A+B Test.</measure>
    <time_frame>1 day</time_frame>
    <description>Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by iTreat Flu A+B Test.</measure>
    <time_frame>1 day</time_frame>
    <description>Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by ellume.lab Flu A+B Test.</measure>
    <time_frame>1 day</time_frame>
    <description>Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by iTreat Flu A+B Test.</measure>
    <time_frame>1 day</time_frame>
    <description>Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by ellume.lab Flu A+B Test.</measure>
    <time_frame>1 day</time_frame>
    <description>Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by iTreat Flu A+B Test.</measure>
    <time_frame>1 day</time_frame>
    <description>Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Of participants positive for influenza A by RT-PCR, the percentage who are positive for influenza A by ellume.lab Flu A+B Test.</measure>
    <time_frame>1 day</time_frame>
    <description>Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by iTreat Flu A+B Test.</measure>
    <time_frame>1 day</time_frame>
    <description>Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by ellume.lab Flu A+B Test.</measure>
    <time_frame>1 day</time_frame>
    <description>Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by iTreat Flu A+B Test.</measure>
    <time_frame>1 day</time_frame>
    <description>Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by ellume.lab Flu A+B Test.</measure>
    <time_frame>1 day</time_frame>
    <description>Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Of participants negative for influenza B by RT-PCR, the percentage who are negative for influenza B by iTreat Flu A+B Test.</measure>
    <time_frame>1 day</time_frame>
    <description>Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Of participants negative for influenza B by RT-PCR, the percentage who are negative for influenza B by ellume.lab Flu A+B Test.</measure>
    <time_frame>1 day</time_frame>
    <description>Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of participants who correctly interpret result of iTreat Flu A+B Test.</measure>
    <time_frame>1 day</time_frame>
    <description>Agreement between trained staff and participants. Report as a percentage of participants with 95% confidence limits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores from questionnaire to assess ease of use, comfort and convenience of iTreat Flu A+B Test.</measure>
    <time_frame>1 day</time_frame>
    <description>The ease of use questionnaire will provide total number of responses to each question and the percentage of participants selecting each response (on a 5 point Likert scale).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores from questionnaire to assess ease of use and convenience of ellume.lab Flu A+B Test.</measure>
    <time_frame>1 day</time_frame>
    <description>The ease of use questionnaire will provide total number of responses to each question and the percentage of participants selecting each response (on a 5 point Likert scale).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">381</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>iTreat Flu A+B Test and ellume.lab Flu A+B Test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Upper respiratory tract samples from participants will be tested with:&#xD;
iTreat Flu A+B Test; ellume.lab Flu A+B Test; Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); and viral culture.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>iTreat Flu A+B Test</intervention_name>
    <description>The iTreat Flu A+B Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal swab samples. The iTreat Flu A+B Test is designed to be simple to use and generates a result within 15 minutes.</description>
    <arm_group_label>iTreat Flu A+B Test and ellume.lab Flu A+B Test</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ellume.lab Flu A+B Test</intervention_name>
    <description>The ellume.lab Flu A+B Test is an in vitro diagnostic test intended to be used at point-of-care for the detection of influenza A or influenza B in nasal swab samples. The ellume.lab Flu A+B Test generates a result within 10 minutes.</description>
    <arm_group_label>iTreat Flu A+B Test and ellume.lab Flu A+B Test</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)</intervention_name>
    <description>Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) is a molecular diagnostic technique for the detection and identification of influenza viruses, both for clinical samples and isolates. The reverse transcriptase polymerase chain reaction (RT-PCR) allows template viral RNA to be reverse transcribed producing complementary DNA (cDNA) which can then be amplified and detected.</description>
    <arm_group_label>iTreat Flu A+B Test and ellume.lab Flu A+B Test</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Viral culture</intervention_name>
    <description>Nasopharyngeal samples will be inoculated into appropriate culture media for influenza viral culture. In this test, the virus is actually grown and further identified in the laboratory as influenza A or B.</description>
    <arm_group_label>iTreat Flu A+B Test and ellume.lab Flu A+B Test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female participants aged ≥ 18 years: iTreat Flu A+B Test and ellume.lab Flu&#xD;
             A+B Test OR aged ≥ 1 and &lt;18 years: ellume.lab Flu A+B Test only; and&#xD;
&#xD;
          -  Fever ≥ 37.8°C (100°F) at presentation or history or parent/guardian-reported history&#xD;
             of fever ≥ 37.8°C (100°F) or feeling feverish within 24 hours of presentation; and&#xD;
&#xD;
          -  Rhonorrhea or blocked nose; and&#xD;
&#xD;
          -  Participant (or parent/legal guardian) capable and willing to give informed&#xD;
             consent/assent; and&#xD;
&#xD;
          -  Participant (or parent/legal guardian) able to read and write in English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants aged &lt;1 year.&#xD;
&#xD;
          -  Participants who have undergone treatment with Tamiflu (oseltamivir), Relenza&#xD;
             (zanamivir) or Symmetral (amantadine) within the previous 7 days.&#xD;
&#xD;
          -  Participants who have been vaccinated by means of an influenza nasal spray/mist&#xD;
             vaccine within the previous 7 days.&#xD;
&#xD;
          -  Participants who have had a nose bleed within the past 30 days.&#xD;
&#xD;
          -  Participants who have had recent craniofacial injury or surgery, including surgery to&#xD;
             correct deviation of the nasal septum, within the previous 6 months.&#xD;
&#xD;
          -  Participants currently enrolled in another clinical trial or have used any&#xD;
             investigational device within 30 days preceding informed consent.&#xD;
&#xD;
          -  Participants 18 years of age or older unable to understand English and consent to&#xD;
             participation.&#xD;
&#xD;
          -  Parent/legal guardian of Paticipants &lt;18 years of age unable to understand English and&#xD;
             consent to participation of child.&#xD;
&#xD;
          -  Participants who have had prior exposure to iTreat Flu A+B Test.&#xD;
&#xD;
          -  participants who have been previously enrolled in the iE-FLU-AUS-1701 study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ochre Health Medical Centre Casey</name>
      <address>
        <city>Casey</city>
        <state>Australian Capital Territory</state>
        <zip>2913</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paratus Clinical Blacktown Trial Clinic</name>
      <address>
        <city>Blacktown</city>
        <state>New South Wales</state>
        <zip>2148</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paratus Clinical Kanwal Trial Clinic</name>
      <address>
        <city>Kanwal</city>
        <state>New South Wales</state>
        <zip>2559</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Family Health</name>
      <address>
        <city>Buddina</city>
        <state>Queensland</state>
        <zip>4575</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morayfield Family Doctors</name>
      <address>
        <city>Morayfield</city>
        <state>Queensland</state>
        <zip>4506</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USC Health Clinics</name>
      <address>
        <city>Sippy Downs</city>
        <state>Queensland</state>
        <zip>4556</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Griffith University Clinical Trial Unit</name>
      <address>
        <city>Southport</city>
        <state>Queensland</state>
        <zip>4125</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emeritus Research</name>
      <address>
        <city>Malvern East</city>
        <state>Victoria</state>
        <zip>3145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>January 30, 2018</last_update_submitted>
  <last_update_submitted_qc>January 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03248960
org study id: iE-FLU-AUS-1701
nct id: NCT03248960
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The primary purpose of this study is to validate the sensitivity and specificity of the
      iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B
      as compared to viral culture.

      The secondary aims are to:

      Validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu
      A+B Test in detecting influenza A and influenza B as compared to Reverse Transcriptase
      Polymerase Chain Reaction (RT-PCR).

      Evaluate the correct interpretation of the iTreat Flu A+B Test by subjects with
      influenza-like symptoms.

      Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the
      iTreat Flu A+B Test.

      Evaluate the operators' satisfaction with the ease of use of the ellume.lab Flu A+B Test.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by iTreat Flu A+B Test.
time frame: 1 day
description: Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
measure: Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by ellume.lab Flu A+B Test.
time frame: 1 day
description: Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
measure: Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by iTreat Flu A+B Test.
time frame: 1 day
description: Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
measure: Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by ellume.lab Flu A+B Test.
time frame: 1 day
description: Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
measure: Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by iTreat Flu A+B Test.
time frame: 1 day
description: Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
measure: Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by ellume.lab Flu A+B Test.
time frame: 1 day
description: Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
measure: Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by iTreat Flu A+B Test.
time frame: 1 day
description: Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
measure: Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by ellume.lab Flu A+B Test.
time frame: 1 day
description: Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
measure: Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by iTreat Flu A+B Test.
time frame: 1 day
description: Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
measure: Of participants positive for influenza A by RT-PCR, the percentage who are positive for influenza A by ellume.lab Flu A+B Test.
time frame: 1 day
description: Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
measure: Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by iTreat Flu A+B Test.
time frame: 1 day
description: Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
measure: Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by ellume.lab Flu A+B Test.
time frame: 1 day
description: Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
measure: Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by iTreat Flu A+B Test.
time frame: 1 day
description: Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
measure: Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by ellume.lab Flu A+B Test.
time frame: 1 day
description: Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
measure: Of participants negative for influenza B by RT-PCR, the percentage who are negative for influenza B by iTreat Flu A+B Test.
time frame: 1 day
description: Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
measure: Of participants negative for influenza B by RT-PCR, the percentage who are negative for influenza B by ellume.lab Flu A+B Test.
time frame: 1 day
description: Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
measure: Percent of participants who correctly interpret result of iTreat Flu A+B Test.
time frame: 1 day
description: Agreement between trained staff and participants. Report as a percentage of participants with 95% confidence limits
measure: Scores from questionnaire to assess ease of use, comfort and convenience of iTreat Flu A+B Test.
time frame: 1 day
description: The ease of use questionnaire will provide total number of responses to each question and the percentage of participants selecting each response (on a 5 point Likert scale).
measure: Scores from questionnaire to assess ease of use and convenience of ellume.lab Flu A+B Test.
time frame: 1 day
description: The ease of use questionnaire will provide total number of responses to each question and the percentage of participants selecting each response (on a 5 point Likert scale).
arm group label: iTreat Flu A+B Test and ellume.lab Flu A+B Test
arm group type: Experimental
description: Upper respiratory tract samples from participants will be tested with:
iTreat Flu A+B Test; ellume.lab Flu A+B Test; Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); and viral culture.
intervention type: Diagnostic Test
intervention name: iTreat Flu A+B Test
description: The iTreat Flu A+B Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal swab samples. The iTreat Flu A+B Test is designed to be simple to use and generates a result within 15 minutes.
arm group label: iTreat Flu A+B Test and ellume.lab Flu A+B Test
intervention type: Diagnostic Test
intervention name: ellume.lab Flu A+B Test
description: The ellume.lab Flu A+B Test is an in vitro diagnostic test intended to be used at point-of-care for the detection of influenza A or influenza B in nasal swab samples. The ellume.lab Flu A+B Test generates a result within 10 minutes.
arm group label: iTreat Flu A+B Test and ellume.lab Flu A+B Test
intervention type: Diagnostic Test
intervention name: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
description: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) is a molecular diagnostic technique for the detection and identification of influenza viruses, both for clinical samples and isolates. The reverse transcriptase polymerase chain reaction (RT-PCR) allows template viral RNA to be reverse transcribed producing complementary DNA (cDNA) which can then be amplified and detected.
arm group label: iTreat Flu A+B Test and ellume.lab Flu A+B Test
intervention type: Diagnostic Test
intervention name: Viral culture
description: Nasopharyngeal samples will be inoculated into appropriate culture media for influenza viral culture. In this test, the virus is actually grown and further identified in the laboratory as influenza A or B.
arm group label: iTreat Flu A+B Test and ellume.lab Flu A+B Test
criteria: 
gender: All
minimum age: 1 Year
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
responsible party type: Sponsor