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

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.

Conditions

• Influenza A
• Influenza B

Interventions

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.

Sponsors & Collaborators

• Ellume Pty Ltd

  lead INDUSTRY

Principal Investigators

• Noel Cranswick · Australian Paediatric Pharmacology Research Unit, Royal Children's Hospital

• James Pollard · Barwon Health - Geelong

• Paul Griffin · Mater Hospital - Brisbane

• Stephen Windley · Doctors@Carindale

• Luke Katahanas · Capalaba Medical Centre

• Bernardine McKellar · Red Hill Doctors Surgery

• Evan Jones · University of Sunshine Coast Clinical Trials Centre

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Year

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-07-31

Primary Completion

2016-10-31

Completion

2016-10-31

Countries

• Australia

Study Locations