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

Influenza A Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Influenza A
• Influenza B
• Influenza, Human

• NCT number: NCT02487173
• Study type: Interventional
• Source: Ellume Pty Ltd
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Completion date: December 2015