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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Influenza

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julie Todhunter, MBBS

Role: PRINCIPAL_INVESTIGATOR

Unaffliated

Locations

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Taringa 7 Day Medical Practice

Brisbane, Queensland, Australia

Site Status

Capalaba Medical Centre