Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.

NACompletedINTERVENTIONAL
Enrollment

381

Participants

Timeline

Start Date

July 27, 2017

Primary Completion Date

December 23, 2017

Study Completion Date

December 23, 2017

Conditions
Influenza
Interventions
DIAGNOSTIC_TEST

iTreat Flu A+B Test

The iTreat Flu A+B Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal swab samples. The iTreat Flu A+B Test is designed to be simple to use and generates a result within 15 minutes.

DIAGNOSTIC_TEST

ellume.lab Flu A+B Test

The ellume.lab Flu A+B 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 nasal swab samples. The ellume.lab Flu A+B Test generates a result within 10 minutes.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Viral culture

Nasopharyngeal samples will be inoculated into appropriate culture media for influenza viral culture. In this test, the virus is actually grown and further identified in the laboratory as influenza A or B.

Trial Locations (8)

2148

Paratus Clinical Blacktown Trial Clinic, Blacktown

2559

Paratus Clinical Kanwal Trial Clinic, Kanwal

2913

Ochre Health Medical Centre Casey, Casey

3145

Emeritus Research, Malvern East

4125

Griffith University Clinical Trial Unit, Southport

4506

Morayfield Family Doctors, Morayfield

4556

USC Health Clinics, Sippy Downs

4575

Coastal Family Health, Buddina

All Listed Sponsors
lead

Ellume Pty Ltd

INDUSTRY

NCT03248960 - Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction. | Biotech Hunter | Biotech Hunter