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Ellume·Lab Flu A+B Test and the Ellume Home Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03595358
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Ellume Pty Ltd

Brief Summary:

The primary purpose of the study is to validate the sensitivity and specificity of the Ellume Home Flu 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)

Secondary aims are to:

Validate the sensitivity and specificity of the Ellume Home Flu Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture; Evaluate the participant's satisfaction with the convenience and ease of use of the Ellume Home Flu Test; Evaluate the participant's interpretation of the Ellume Home Flu Test results compared to the interpretation by site staff; Evaluate the operator's satisfaction and ease of use of the ellume·lab Flu A+B Test.


Condition or disease Intervention/treatment Phase
Influenza Diagnostic Test: Ellume Home Flu Test Diagnostic Test: ellume.lab Flu A+B Test Diagnostic Test: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Diagnostic Test: Viral culture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective Multi-Centre Study of the Ellume·Lab Flu A+B Test and the Ellume Home Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction
Actual Study Start Date : August 31, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu

Arm Intervention/treatment
Experimental: Arm

Ellume Home Flu Test and ellume.lab Flu A+B Test

Upper respiratory tract samples from participants will be tested with:

Ellume Home Flu Test; ellume.lab Flu A+B Test; Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and viral culture.

Diagnostic Test: Ellume Home Flu Test
The Ellume Home Flu Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal swab samples.

Diagnostic Test: ellume.lab Flu A+B Test
The ellume.lab Flu A+B Test is a rapid 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.

Diagnostic Test: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
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.

Diagnostic Test: Viral culture
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.




Primary Outcome Measures :
  1. Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by Ellume Home Flu Test. [ Time Frame: 1 day ]
    Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.

  2. Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by ellume.lab Flu A+B Test. [ Time Frame: 1 day ]
    Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.

  3. Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by Ellume Home Flu Test. [ Time Frame: 1 day ]
    Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.

  4. Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by ellume.lab Flu A+B Test. [ Time Frame: 1 day ]
    Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.

  5. Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza B by Ellume Home Flu Test. [ Time Frame: 1 day ]
    Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.

  6. Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza B by ellume.lab Flu A+B Test. [ Time Frame: 1 day ]
    Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.

  7. Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza B by Ellume Home Flu Test. [ Time Frame: 1 day ]
    Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.

  8. Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza B by ellume.lab Flu A+B Test. [ Time Frame: 1 day ]
    Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.


Secondary Outcome Measures :
  1. Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by Ellume Home Flu Test. [ Time Frame: 1 day ]
    Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.

  2. 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: 1day ]
    Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.

  3. Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by Ellume Home Flu Test. [ Time Frame: 1 day ]
    Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.

  4. 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 ]
    Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.

  5. Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by Ellume Home Flu Test. [ Time Frame: 1 day ]
    Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.

  6. 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 ]
    Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.

  7. Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by Ellume Home Flu Test. [ Time Frame: 1 day ]
    Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.

  8. 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 ]
    Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.

  9. Percent of participants who correctly interpret the result of the Ellume Home Flu Test [ Time Frame: 1 day ]
    Agreement between trained staff and participants. Report as a percentage of participants with 96% confidence limits.

  10. Scores from questionnaire to assess ease of use, comfort and convenience of the Ellume Home Flu Test. [ Time Frame: 1 day ]
    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).

  11. Scores from questionnaire to assess ease of use and convenience of the ellume.lab Flu A+B Test. [ Time Frame: 1 day ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female participants aged ≥ 2 years; and
  • Fever ≥ 37.8° C (100° F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8° C or feeling feverish within 24 hours of presentation; and
  • Rhinorrhea; and
  • ≤ 72 hours from onset of ILI symptoms; and
  • Participant (or parent/legal guardian) capable and willing to give informed consent/assent; and
  • Participant (or parent/legal guardian) able to read and write in English.

Exclusion Criteria:

  • Participants aged < 2 years.
  • Participants who have undergone treatment with Tamiflu (oseltamivir), Relenza (zanamivir) or Symmetral (amantadine) within the previous 7 days;
  • Participants who have been vaccinated by means of an Influenza nasal spray/mist vaccine within the previous 7 days;
  • Participants who have had a nose bleed within the past 30 days;
  • Participants who have had recent craniofacial injury or surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months;
  • Participants currently enrolled in another clinical trial or used any investigational device within 30 days preceding informed consent.
  • Participants previously enrolled in IE-FLU-AUS-1801;
  • Participants 18 years of age or older unable to understand English and consent to participation;
  • Parent/legal guardian of participants < 18 years of age unable to understand English and consent to participation of child.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03595358


Contacts
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Contact: Debbie Brezac +61 7 33931448 debbie.brezac@ellume.com.au

Locations
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Australia, New South Wales
Paratus Clinical Kanwal Trial Clinic Recruiting
Kanwal, New South Wales, Australia, 2559
Sponsors and Collaborators
Ellume Pty Ltd
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Responsible Party: Ellume Pty Ltd
ClinicalTrials.gov Identifier: NCT03595358    
Other Study ID Numbers: IE-FLU-AUS-1801
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No