Ellume·Lab Flu A+B Test and the Ellume Home Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction

NACompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

August 31, 2018

Primary Completion Date

November 16, 2018

Study Completion Date

November 16, 2018

Conditions
Influenza
Interventions
DIAGNOSTIC_TEST

Ellume Home Flu Test

The Ellume Home Flu Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal swab samples.

DIAGNOSTIC_TEST

ellume.lab Flu A+B Test

The ellume.lab Flu A+B Test is a rapid 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.

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 (1)

2559

Paratus Clinical Kanwal Trial Clinic, Kanwal

All Listed Sponsors
lead

Ellume Pty Ltd

INDUSTRY

NCT03595358 - Ellume·Lab Flu A+B Test and the Ellume Home Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction | Biotech Hunter | Biotech Hunter