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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of Influenza A | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of Influenza B | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Todhunter, MBBS | Unaffliated | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taringa 7 Day Medical Practice | Brisbane | Queensland | 4068 | Australia | ||
| Capalaba Medical Centre |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
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| Brisbane |
| Queensland |
| 4157 |
| Australia |