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

NACompletedINTERVENTIONAL
Enrollment

1,500

Participants

Timeline

Start Date

July 31, 2016

Primary Completion Date

October 31, 2016

Study Completion Date

October 31, 2016

Conditions
Influenza AInfluenza 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.

Trial Locations (7)

3052

The Royal Children's Hospital, Melbourne

3220

Barwon Health - Geelong, Geelong

4059

Red Hill Doctors Surgery, Brisbane

4101

Mater Hospital - Brisbane, Brisbane

4152

Doctors@Carindale, Brisbane

4157

Capalaba Medical Centre, Redland

4556

Clinical Trials Centre - University of the Sunshine Coast, Sippy Downs

All Listed Sponsors
lead

Ellume Pty Ltd

INDUSTRY

NCT02767414 - Validation of the Ellume® Respirio Flu Test and the Ellume® eLab Flu Test for the Rapid Identification of Influenza A/B | Biotech Hunter | Biotech Hunter