Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.

A Prospective Multi-Centre Study of the Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.

The primary purpose of this study is 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 viral culture.

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Diagnostic test: iTreat Flu A+B Test; Diagnostic test: ellume.lab Flu A+B Test; Diagnostic test: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); Diagnostic test: Viral culture

• Study Type: Interventional
• Enrollment (Actual): 381
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Casey, Australian Capital Territory, Australia, 2913
      • Ochre Health Medical Centre Casey
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Paratus Clinical Blacktown Trial Clinic
    • Kanwal, New South Wales, Australia, 2559
      • Paratus Clinical Kanwal Trial Clinic
  • Queensland
    • Buddina, Queensland, Australia, 4575
      • Coastal Family Health
    • Morayfield, Queensland, Australia, 4506
      • Morayfield Family Doctors
    • Sippy Downs, Queensland, Australia, 4556
      • USC Health Clinics
    • Southport, Queensland, Australia, 4125
      • Griffith University Clinical Trial Unit
  • Victoria
    • Malvern East, Victoria, Australia, 3145
      • Emeritus Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female participants aged ≥ 18 years: iTreat Flu A+B Test and ellume.lab Flu A+B Test OR aged ≥ 1 and <18 years: ellume.lab Flu A+B Test only; and
• 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 aged <1 year.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

Diagnostic test: 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.; Diagnostic test: 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.; Diagnostic test: 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.; Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by iTreat Flu A+B Test.	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.	1 day
Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by ellume.lab Flu A+B Test.	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.	1 day
Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by iTreat Flu A+B Test.	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.	1 day
Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by ellume.lab Flu A+B Test.	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.	1 day
Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by iTreat Flu A+B Test.	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.	1 day
Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by ellume.lab Flu A+B Test.	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.	1 day
Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by iTreat Flu A+B Test.	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.	1 day
Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by ellume.lab Flu A+B Test.	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by iTreat Flu A+B Test.	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.	1 day
Of participants positive for influenza A by RT-PCR, the percentage who are positive for influenza A by ellume.lab Flu A+B Test.	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.	1 day
Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by iTreat Flu A+B Test.	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.	1 day
Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by ellume.lab Flu A+B Test.	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.	1 day
Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by iTreat Flu A+B Test.	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.	1 day
Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by ellume.lab Flu A+B Test.	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.	1 day
Of participants negative for influenza B by RT-PCR, the percentage who are negative for influenza B by iTreat Flu A+B Test.	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.	1 day
Of participants negative for influenza B by RT-PCR, the percentage who are negative for influenza B by ellume.lab Flu A+B Test.	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.	1 day
Percent of participants who correctly interpret result of iTreat Flu A+B Test.	Agreement between trained staff and participants. Report as a percentage of participants with 95% confidence limits	1 day
Scores from questionnaire to assess ease of use, comfort and convenience of iTreat Flu A+B Test.	The ease of use questionnaire will provide total number of responses to each question and the percentage of participants selecting each response (on a 5 point Likert scale).	1 day
Scores from questionnaire to assess ease of use and convenience of ellume.lab Flu A+B Test.	The ease of use questionnaire will provide total number of responses to each question and the percentage of participants selecting each response (on a 5 point Likert scale).	1 day

Collaborators and Investigators

• Sponsor: Ellume Pty Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 27, 2017
• Primary Completion (ACTUAL): December 23, 2017
• Study Completion (ACTUAL): December 23, 2017

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 10, 2017
• First Posted (ACTUAL): August 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2018
• Last Update Submitted That Met QC Criteria: January 30, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: iE-FLU-AUS-1701

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No