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

NCT01431768 | Completed

• 1 other identifier: RESP11001
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Influenza

Keywords

Influenza; Human; Orthomyxoviridae infections; RNA Virus Infections; Virus Diseases; Respiratory Tract infections; Respiratory Tract Diseases

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of Influenza A

  Day 1

Secondary Outcomes (1)

• Sensitivity and specificity of Influenza B

  Day 1

Interventions

Respirio Flu Test DEVICE

The Respirio Flu Test (RFT) is a rapid test for identifying whether a patient is infected with the Influenza A or B virus. The test separates the Influenza virus from the patient's nose blow sample and utilizes the same underlying technology as a pregnancy test (lateral flow/immuno-chromatography) to deliver a positive or negative result in less than 10 minutes. The RFT is easy to use, designed with a 3 step process similar to that of the home pregnancy test. Results are presented to the patient as a combination of different coloured lines, depending on whether the patient has Influenza A or B.

Eligibility Criteria

• Age: 7 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Respirio Pty Ltd: lead

Study Sites (2)

Taringa 7 Day Medical Practice

Brisbane, Queensland, 4068, Australia

Location

Capalaba Medical Centre

Brisbane, Queensland, 4157, Australia

Location

MeSH Terms

Conditions

Influenza, Human; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Julie Todhunter, MBBS

  Unaffliated

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2011
• First Posted: September 12, 2011
• Study Start: July 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 30, 2014

Record last verified: 2014-04

Locations

AU (2)