Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.
NCT ID: NCT03248960
Last Updated: 2018-02-01
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
381 participants
INTERVENTIONAL
2017-07-27
2017-12-23
Brief Summary
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The secondary aims are to:
Validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).
Evaluate the correct interpretation of the iTreat Flu A+B Test by subjects with influenza-like symptoms.
Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the iTreat Flu A+B Test.
Evaluate the operators' satisfaction with the ease of use of the ellume.lab Flu A+B Test.
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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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iTreat Flu A+B Test and ellume.lab Flu A+B Test
Upper respiratory tract samples from participants will be tested with:
iTreat Flu A+B Test; ellume.lab Flu A+B Test; Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); and viral culture.
iTreat Flu A+B Test
The iTreat Flu A+B Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal swab samples. The iTreat Flu A+B Test is designed to be simple to use and generates a result within 15 minutes.
ellume.lab Flu A+B Test
The ellume.lab Flu A+B 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 nasal swab samples. The ellume.lab Flu A+B 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.
Viral culture
Nasopharyngeal samples will be inoculated into appropriate culture media for influenza viral culture. In this test, the virus is actually grown and further identified in the laboratory as influenza A or B.
Interventions
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iTreat Flu A+B Test
The iTreat Flu A+B Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal swab samples. The iTreat Flu A+B Test is designed to be simple to use and generates a result within 15 minutes.
ellume.lab Flu A+B Test
The ellume.lab Flu A+B 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 nasal swab samples. The ellume.lab Flu A+B 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.
Viral culture
Nasopharyngeal samples will be inoculated into appropriate culture media for influenza viral culture. In this test, the virus is actually grown and further identified in the laboratory as influenza A or B.
Eligibility Criteria
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Inclusion Criteria
* Fever ≥ 37.8°C (100°F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8°C (100°F) or feeling feverish within 24 hours of presentation; and
* Rhonorrhea or blocked nose; and
* Participant (or parent/legal guardian) capable and willing to give informed consent/assent; and
* Participant (or parent/legal guardian) able to read and write in English.
Exclusion Criteria
* Participants who have undergone treatment with Tamiflu (oseltamivir), Relenza (zanamivir) or Symmetral (amantadine) within the previous 7 days.
* Participants who have been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.
* Participants who have had a nose bleed within the past 30 days.
* Participants who have had recent craniofacial injury or surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months.
* Participants currently enrolled in another clinical trial or have used any investigational device within 30 days preceding informed consent.
* Participants 18 years of age or older unable to understand English and consent to participation.
* Parent/legal guardian of Paticipants \<18 years of age unable to understand English and consent to participation of child.
* Participants who have had prior exposure to iTreat Flu A+B Test.
* participants who have been previously enrolled in the iE-FLU-AUS-1701 study.
1 Year
ALL
No
Sponsors
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Ellume Pty Ltd
INDUSTRY
Responsible Party
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Locations
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Ochre Health Medical Centre Casey
Casey, Australian Capital Territory, Australia
Paratus Clinical Blacktown Trial Clinic
Blacktown, New South Wales, Australia
Paratus Clinical Kanwal Trial Clinic
Kanwal, New South Wales, Australia
Coastal Family Health
Buddina, Queensland, Australia
Morayfield Family Doctors
Morayfield, Queensland, Australia
USC Health Clinics
Sippy Downs, Queensland, Australia
Griffith University Clinical Trial Unit
Southport, Queensland, Australia
Emeritus Research
Malvern East, Victoria, Australia
Countries
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Other Identifiers
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iE-FLU-AUS-1701
Identifier Type: -
Identifier Source: org_study_id
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