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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

Primary Purpose

Influenza A, Influenza B

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Respirio Flu Test
eLab Flu Test
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Sponsored by
Ellume Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Influenza A

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Red Hill Doctors Surgery
  • Mater Hospital - Brisbane
  • Doctors@Carindale
  • Capalaba Medical Centre
  • Clinical Trials Centre - University of the Sunshine Coast
  • Barwon Health - Geelong
  • The Royal Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Respirio Flu Test and eLab Flu Test

Arm Description

Upper respiratory tract samples from participants will be tested with: Respirio Flu Test; eLab Flu Test; and Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

Outcomes

Primary Outcome Measures

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.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
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.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
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.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
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.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.

Secondary Outcome Measures

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.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
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.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
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.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
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.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Percent of participants who correctly interpret result of Respirio Flu Test.
Agreement between trained staff and participants. Report as a percentage of participants with 95% confidence limits.
Scores from questionnaire to assess ease of use, comfort and convenience of Respirio Flu Test.
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).

Full Information

First Posted
May 6, 2016
Last Updated
December 4, 2016
Sponsor
Ellume Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02767414
Brief Title
Validation of the Ellume® Respirio Flu Test and the Ellume® eLab Flu Test for the Rapid Identification of Influenza A/B
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 Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ellume Pty Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza A, Influenza B

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Respirio Flu Test and eLab Flu Test
Arm Type
Experimental
Arm Description
Upper respiratory tract samples from participants will be tested with: Respirio Flu Test; eLab Flu Test; and Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Intervention Type
Device
Intervention Name(s)
Respirio Flu Test
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
eLab Flu Test
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Intervention 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.
Primary Outcome Measure Information:
Title
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.
Description
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Time Frame
Day 1
Title
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.
Description
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Time Frame
Day 1
Title
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.
Description
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Time Frame
Day 1
Title
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.
Description
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
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.
Description
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Time Frame
Day 1
Title
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.
Description
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Time Frame
Day 1
Title
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.
Description
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Time Frame
Day 1
Title
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.
Description
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Time Frame
Day 1
Title
Percent of participants who correctly interpret result of Respirio Flu Test.
Description
Agreement between trained staff and participants. Report as a percentage of participants with 95% confidence limits.
Time Frame
Day 1
Title
Scores from questionnaire to assess ease of use, comfort and convenience of Respirio Flu Test.
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).
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noel Cranswick
Organizational Affiliation
Australian Paediatric Pharmacology Research Unit, Royal Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Pollard
Organizational Affiliation
Barwon Health - Geelong
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Griffin
Organizational Affiliation
Mater Hospital - Brisbane
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Windley
Organizational Affiliation
Doctors@Carindale
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luke Katahanas
Organizational Affiliation
Capalaba Medical Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bernardine McKellar
Organizational Affiliation
Red Hill Doctors Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Evan Jones
Organizational Affiliation
University of Sunshine Coast Clinical Trials Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Red Hill Doctors Surgery
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4059
Country
Australia
Facility Name
Mater Hospital - Brisbane
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Doctors@Carindale
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4152
Country
Australia
Facility Name
Capalaba Medical Centre
City
Redland
State/Province
Queensland
ZIP/Postal Code
4157
Country
Australia
Facility Name
Clinical Trials Centre - University of the Sunshine Coast
City
Sippy Downs
State/Province
Queensland
ZIP/Postal Code
4556
Country
Australia
Facility Name
Barwon Health - Geelong
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
The Royal Children's Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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