Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B
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|ClinicalTrials.gov Identifier: NCT01431768|
Recruitment Status : Completed
First Posted : September 12, 2011
Last Update Posted : April 30, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Device: Respirio Flu Test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B in the Primary Health Setting|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
- 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.
- Sensitivity and specificity of Influenza A [ Time Frame: Day 1 ]
- Sensitivity and specificity of Influenza B [ Time Frame: Day 1 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431768
|Taringa 7 Day Medical Practice|
|Brisbane, Queensland, Australia, 4068|
|Capalaba Medical Centre|
|Brisbane, Queensland, Australia, 4157|
|Principal Investigator:||Julie Todhunter, MBBS||Unaffliated|