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

Study Overview
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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.

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

Conditions
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Influenza

Intervention / Treatment
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* Device: Respirio Flu Test


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of Influenza A |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of Influenza B |  | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Human, Orthomyxoviridae infections, RNA Virus Infections, Virus Diseases, Respiratory Tract infections, Respiratory Tract Diseases