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

Respirio Pty Ltd250 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

250

Conditions

Influenza

Interventions

Respirio Flu TestDEVICE

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

Sex: ALLMin age: 7 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (2)

Taringa 7 Day Medical Practice

Brisbane, Queensland, Australia

Capalaba Medical Centre

Brisbane, Queensland, Australia

Outcomes

Primary Outcomes

Sensitivity and specificity of Influenza A

Time frame: Day 1

Secondary Outcomes

Sensitivity and specificity of Influenza B

Time frame: Day 1

Data from ClinicalTrials.gov

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