Validation of the Ellume® Respirio Flu Test and the Ellume® eLab Flu Test for the Rapid Identification of Influenza A/B
NCT ID: NCT02767414
Last Updated: 2016-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1500 participants
INTERVENTIONAL
2016-07-31
2016-10-31
Brief Summary
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The secondary aims are to:
Validate the sensitivity and specificity of the Respirio Flu Test and the eLab Flu Test in detecting Influenza B as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); Evaluate the correct interpretation of the Respirio Flu Test by subjects with influenza-like symptoms; Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the Respirio Flu Test.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Respirio Flu Test and eLab Flu Test
Upper respiratory tract samples from participants will be tested with:
Respirio Flu Test; eLab Flu Test; and Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Respirio Flu Test
The Respirio Flu Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal secretions. The Respirio Flu Test is designed to be simple to use and generates a result within 20 minutes.
eLab Flu Test
The eLab Flu Test is an in vitro diagnostic test intended to be used at point-of-care for the detection of influenza A or influenza B in nasopharyngeal swab samples. The eLab Flu Test generates a result within 10 minutes.
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) is a molecular diagnostic technique for the detection and identification of influenza viruses, both for clinical samples and isolates. The reverse transcriptase polymerase chain reaction (RT-PCR) allows template viral RNA to be reverse transcribed producing complementary DNA (cDNA) which can then be amplified and detected.
Interventions
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Respirio Flu Test
The Respirio Flu Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal secretions. The Respirio Flu Test is designed to be simple to use and generates a result within 20 minutes.
eLab Flu Test
The eLab Flu Test is an in vitro diagnostic test intended to be used at point-of-care for the detection of influenza A or influenza B in nasopharyngeal swab samples. The eLab Flu Test generates a result within 10 minutes.
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) is a molecular diagnostic technique for the detection and identification of influenza viruses, both for clinical samples and isolates. The reverse transcriptase polymerase chain reaction (RT-PCR) allows template viral RNA to be reverse transcribed producing complementary DNA (cDNA) which can then be amplified and detected.
Eligibility Criteria
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Inclusion Criteria
* Rhinorrhea;
* ≤ 5 days from onset of influenza-like illness symptoms;
* Subject (or parent/legal guardian) capable and willing to give informed consent/assent;
* Subject (or parent/legal guardian) able to read and write English.
Exclusion Criteria
* Has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days;
* Recent craniofacial injury or surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months;
* Currently enrolled in another clinical trial or used any investigational device within 90 days preceding informed consent;
* Has had prior exposure to the Respirio Flu Test or eLab Flu Test.
1 Year
ALL
No
Sponsors
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Ellume Pty Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Noel Cranswick
Role: PRINCIPAL_INVESTIGATOR
Australian Paediatric Pharmacology Research Unit, Royal Children's Hospital
James Pollard
Role: PRINCIPAL_INVESTIGATOR
Barwon Health - Geelong
Paul Griffin
Role: PRINCIPAL_INVESTIGATOR
Mater Hospital - Brisbane
Stephen Windley
Role: PRINCIPAL_INVESTIGATOR
Doctors@Carindale
Luke Katahanas
Role: PRINCIPAL_INVESTIGATOR
Capalaba Medical Centre
Bernardine McKellar
Role: PRINCIPAL_INVESTIGATOR
Red Hill Doctors Surgery
Evan Jones
Role: PRINCIPAL_INVESTIGATOR
University of Sunshine Coast Clinical Trials Centre
Locations
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Red Hill Doctors Surgery
Brisbane, Queensland, Australia
Mater Hospital - Brisbane
Brisbane, Queensland, Australia
Doctors@Carindale
Brisbane, Queensland, Australia
Capalaba Medical Centre
Redland, Queensland, Australia
Clinical Trials Centre - University of the Sunshine Coast
Sippy Downs, Queensland, Australia
Barwon Health - Geelong
Geelong, Victoria, Australia
The Royal Children's Hospital
Melbourne, Victoria, Australia
Countries
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Other Identifiers
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RESP16001
Identifier Type: -
Identifier Source: org_study_id