NCT02487173

Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B

A Prospective Multi-Centre Study of the Respirio Flu Test Performance Versus Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and Sofia® Influenza A+B Fluorescent Immunoassay (FIA) for the Rapid Detection of Influenza A/B

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 83 (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 in detecting Influenza A, when used by subjects, 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 in detecting Influenza B , when used by subjects, as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR). * assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza A+B Test in detecting Influenza A; * assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza A+B Test in detecting Influenza B; * evaluate the correct interpretation of the Respirio Flu Test results by subjects with Influenza-like illness symptoms; * evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the Respirio Flu Test; * evaluate the subjects' comprehension of the Respirio Flu Test labelling; and * establish the minimum sample weight required to achieve a result with the Respirio Flu Test.

Conditions

• Influenza A
• Influenza B

Interventions

Type	Name	Description
DEVICE	Respirio Flu Test	The Respirio Flu Test is a rapid 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	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.
DEVICE	Sofia® Influenza A+B Fluorescent Immunoassay (FIA)	Sofia® Influenza A+B Fluorescent Immunoassay (FIA) employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash samples taken directly from symptomatic patients.

Timeline

• Start date: 2015-09-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-07-01
• Last updated: 2016-07-15

Locations

4 sites across 1 country: Australia