Influenza
Conditions
Keywords
Influenza, Human, Orthomyxoviridae infections, RNA Virus Infections, Virus Diseases, Respiratory Tract infections, Respiratory Tract Diseases
Brief 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.
Interventions
DEVICERespirio 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.
Sponsors
Respirio Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of Influenza A | Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of Influenza B | Day 1 |
Countries
Australia
Outcome results
None listed