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

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

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.

Study Overview

• Status: Completed
• Conditions: Influenza A; Influenza B
• Intervention / Treatment: Device: Respirio Flu Test; Device: eLab Flu Test; Device: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

• Study Type: Interventional
• Enrollment (Actual): 1500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4059
      • Red Hill Doctors Surgery
    • Brisbane, Queensland, Australia, 4101
      • Mater Hospital - Brisbane
    • Brisbane, Queensland, Australia, 4152
      • Doctors@Carindale
    • Redland, Queensland, Australia, 4157
      • Capalaba Medical Centre
    • Sippy Downs, Queensland, Australia, 4556
      • Clinical Trials Centre - University of the Sunshine Coast
  • Victoria
    • Geelong, Victoria, Australia, 3220
      • Barwon Health - Geelong
    • Melbourne, Victoria, Australia, 3052
      • The Royal Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1
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.	Day 1
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.	Day 1
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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1
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.	Day 1
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.	Day 1
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.	Day 1
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.	Day 1
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).	Day 1

Collaborators and Investigators

• Sponsor: Ellume Pty Ltd
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: May 6, 2016
• First Submitted That Met QC Criteria: May 9, 2016
• First Posted (Estimate): May 10, 2016

Study Record Updates

• Last Update Posted (Estimate): December 6, 2016
• Last Update Submitted That Met QC Criteria: December 4, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: RESP16001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No