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Validation of the Ellume® Respirio Flu Test and the Ellume® eLab Flu Test for the Rapid Identification of Influenza A/B

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02767414
Recruitment Status : Completed
First Posted : May 10, 2016
Last Update Posted : December 6, 2016
Sponsor:
Information provided by (Responsible Party):
Ellume Pty Ltd

Study Description
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Brief Summary:

The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test and the eLab Flu Test in detecting Influenza A as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).

The secondary aims are to:

Validate the sensitivity and specificity of the Respirio Flu Test and the eLab Flu Test in detecting Influenza B as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); Evaluate the correct interpretation of the Respirio Flu Test by subjects with influenza-like symptoms; Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the Respirio Flu Test.


Condition or disease Intervention/treatment Phase
Influenza A Influenza B Device: Respirio Flu Test Device: eLab Flu Test Device: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1500 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® Respirio Flu Test and the Ellume® eLab Flu Test Performance Versus Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) for the Rapid Detection of Influenza A/B
Study Start Date : July 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arms and Interventions
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Arm Intervention/treatment
Experimental: Respirio Flu Test and eLab Flu Test

Upper respiratory tract samples from participants will be tested with:

Respirio Flu Test; eLab Flu Test; and Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

 Device: Respirio Flu Test
The Respirio Flu Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal secretions. The Respirio Flu Test is designed to be simple to use and generates a result within 20 minutes.

Device: eLab Flu Test
The eLab Flu 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 nasopharyngeal swab samples. The eLab Flu Test generates a result within 10 minutes.

Device: 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.


Outcome Measures
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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 Respirio Flu Test. [ Time Frame: Day 1 ]
    Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.

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

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

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


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

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

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

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

  5. Percent of participants who correctly interpret result of Respirio Flu Test. [ Time Frame: Day 1 ]
    Agreement between trained staff and participants. Report as a percentage of participants with 95% confidence limits.

  6. Scores from questionnaire to assess ease of use, comfort and convenience of Respirio Flu Test. [ Time Frame: Day 1 ]
    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).


Eligibility Criteria
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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:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects aged ≥ 1 year;
  • Rhinorrhea;
  • ≤ 5 days from onset of influenza-like illness symptoms;
  • Subject (or parent/legal guardian) capable and willing to give informed consent/assent;
  • Subject (or parent/legal guardian) able to read and write English.

Exclusion Criteria:

  • Has undergone treatment with antivirals within the previous 7 days;
  • Has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days;
  • Recent craniofacial injury or surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months;
  • Currently enrolled in another clinical trial or used any investigational device within 90 days preceding informed consent;
  • Has had prior exposure to the Respirio Flu Test or eLab Flu Test.
Contacts and Locations
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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): NCT02767414


Locations
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Australia, Queensland
Red Hill Doctors Surgery
Brisbane, Queensland, Australia, 4059
Mater Hospital - Brisbane
Brisbane, Queensland, Australia, 4101
Doctors@Carindale
Brisbane, Queensland, Australia, 4152
Capalaba Medical Centre
Redland, Queensland, Australia, 4157
Clinical Trials Centre - University of the Sunshine Coast
Sippy Downs, Queensland, Australia, 4556
Australia, Victoria
Barwon Health - Geelong
Geelong, Victoria, Australia, 3220
The Royal Children's Hospital
Melbourne, Victoria, Australia, 3052
Sponsors and Collaborators
Ellume Pty Ltd
Investigators
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Principal Investigator: Noel Cranswick Australian Paediatric Pharmacology Research Unit, Royal Children's Hospital
Principal Investigator: James Pollard Barwon Health - Geelong
Principal Investigator: Paul Griffin Mater Hospital - Brisbane
Principal Investigator: Stephen Windley Doctors@Carindale
Principal Investigator: Luke Katahanas Capalaba Medical Centre
Principal Investigator: Bernardine McKellar Red Hill Doctors Surgery
Principal Investigator: Evan Jones University of Sunshine Coast Clinical Trials Centre
More Information
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Responsible Party: Ellume Pty Ltd
ClinicalTrials.gov Identifier: NCT02767414    
Other Study ID Numbers: RESP16001
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases