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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01431768
• Other study ID #: RESP11001
• Status: Completed
• Phase: N/A
• First received: September 7, 2011
• Last updated: April 28, 2014
• Start date: July 2011
• Est. completion date: January 2012

Study information

• Verified date: April 2014
• Source: Respirio Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Device:
• Respirio Flu Test
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.

Locations

Country	Name	City	State
Australia	Capalaba Medical Centre	Brisbane	Queensland
Australia	Taringa 7 Day Medical Practice	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Respirio Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of Influenza A		Day 1	No
Secondary	Sensitivity and specificity of Influenza B		Day 1	No