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

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.

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Key information

Conditions

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

Age range

7 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Capalaba Medical Centre, Brisbane, Queensland, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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.

Primary outcomes

Sensitivity and specificity of Influenza A

Time frame: Day 1

Secondary outcomes

Sensitivity and specificity of Influenza B

Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Respirio Pty Ltd

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Sep 12, 2011
Registry last updated: Apr 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed