NCT02767414

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

A Prospective Multi-centre Study of the Ellume® Respirio Flu Test and the Ellume® eLab Flu Test Performance Versus Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) for the Rapid Detection of Influenza A/B

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,500 (actual)
• Sponsor: Ellume Pty Ltd · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2016-07-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2016-05-10
• Last updated: 2016-12-06

Locations

7 sites across 1 country: Australia