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

Clinical Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B in the Primary Health Setting

This is a open label, prospective, pair comparison, randomised, multi-centre trial. The primary aim of this study to is to clinically validate the sensitivity and specificity of the Respirio Flu Test (RFT) in detecting Influenza A as compared with (a) the best available rapid Influenza A test in the market Quidel QuickVue (QQV) and (b) the gold standard for identifying Influenza A infection Polymerase Chain Reaction (PCR).

The secondary aim is to clinically validate the sensitivity and specificity of the Respirio Flu Test (RFT) in detecting Influenza B as compared to QQV and PCR.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Device: Respirio Flu Test

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4068
      • Taringa 7 Day Medical Practice
    • Brisbane, Queensland, Australia, 4157
      • Capalaba Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 80 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male and female subjects aged between 7 and 80 years (inclusive);
2. Fever > 37.5 or a self-reported history of fever or feeling feverish (includes fever controlled by medication) in the absence of documented fever;
3. Cough or sore throat;
4. Rhinorrhea or nasal congestion;
5. ≤ 5 days from onset of clinical Influenza - Like Illness (ILI) symptoms;
6. Subject (or parent/guardian) capable and willing to give informed consent;
7. Subject provides written assent according to his/her age, if applicable.

Exclusion Criteria:

1. Recent craniofacial abnormality or injury (last 3 months);
2. Nasal or sinus surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months;
3. Craniofacial abnormality, such as severe deviation of the nasal septum;
4. Onset of clinical Influenza - Like Illness (ILI) symptoms > 5 days;
5. Know history of allergic reaction to plastics or adhesives;
6. Subject (or parent/guardian) unwilling or unable to give informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity and specificity of Influenza A	Day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Sensitivity and specificity of Influenza B	Day 1

Collaborators and Investigators

• Sponsor: Respirio Pty Ltd
• Investigators: Principal Investigator: Julie Todhunter, MBBS, unaffliated

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ACTUAL): January 1, 2012
• Study Completion (ACTUAL): January 1, 2012

Study Registration Dates

• First Submitted: September 7, 2011
• First Submitted That Met QC Criteria: September 9, 2011
• First Posted (ESTIMATE): September 12, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): April 30, 2014
• Last Update Submitted That Met QC Criteria: April 28, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Respiratory Tract Diseases; Influenza; Virus Diseases; Human; RNA Virus Infections; Orthomyxoviridae infections; Respiratory Tract infections
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: RESP11001