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

Ellume Pty Ltd1,500 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

1,500

Conditions

Influenza A Influenza B

Interventions

Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)DEVICE

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.

Eligibility

Sex: ALLMin age: 1 Year

Medical Language ↔ Plain English

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.

Locations (7)

Red Hill Doctors Surgery

Brisbane, Queensland, Australia

Mater Hospital - Brisbane

Brisbane, Queensland, Australia

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Day 1

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: Day 1