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

Not Applicable

Completed

• Conditions: Influenza B; Influenza A
• Interventions: Device: Respirio Flu Test; Device: eLab Flu Test; Device: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

• Registration Number: NCT02767414
• Lead Sponsor: Ellume Pty Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-06
• Study First Submitted QC: 2016-05-09
• Study First Posted: 2016-05-10
• Study Start: 2016-07
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-04
• Last Update Posted: 2016-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.	Day 1	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.	Day 1	Establish specificity 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.	Day 1	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 Respirio Flu Test.	Day 1	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.

Secondary Outcome Measures

Name	Time	Method
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.	Day 1	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.	Day 1	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.	Day 1	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.	Day 1	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.	Day 1	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.	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).

Trial Locations

Locations (7)

Doctors@Carindale; 🇦🇺 Brisbane, Queensland, Australia

Capalaba Medical Centre; 🇦🇺 Redland, Queensland, Australia

Clinical Trials Centre - University of the Sunshine Coast; 🇦🇺 Sippy Downs, Queensland, Australia

Barwon Health - Geelong; 🇦🇺 Geelong, Victoria, Australia

The Royal Children's Hospital; 🇦🇺 Melbourne, Victoria, Australia

Mater Hospital - Brisbane; 🇦🇺 Brisbane, Queensland, Australia

Red Hill Doctors Surgery; 🇦🇺 Brisbane, Queensland, Australia