Ellume·Lab Flu A+B Test and the Ellume Home 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 the Ellume Home Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction

The primary purpose of the study is to validate the sensitivity and specificity of the Ellume Home Flu 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)

Secondary aims are to:

Validate the sensitivity and specificity of the Ellume Home Flu Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture; Evaluate the participant's satisfaction with the convenience and ease of use of the Ellume Home Flu Test; Evaluate the participant's interpretation of the Ellume Home Flu Test results compared to the interpretation by site staff; Evaluate the operator's satisfaction and ease of use of the ellume·lab Flu A+B Test.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Debbie Brezac; Phone Number: +61 7 33931448; Email: debbie.brezac@ellume.com.au

Study Locations

• Australia
  • New South Wales
    • Kanwal, New South Wales, Australia, 2559
      • Paratus Clinical Kanwal Trial Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male and female participants aged ≥ 2 years; and
• Fever ≥ 37.8° C (100° F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8° C or feeling feverish within 24 hours of presentation; and
• Rhinorrhea; and
• ≤ 72 hours from onset of ILI symptoms; 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 < 2 years.
• 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 used any investigational device within 30 days preceding informed consent.
• Participants previously enrolled in IE-FLU-AUS-1801;
• Participants 18 years of age or older unable to understand English and consent to participation;
• Parent/legal guardian of participants < 18 years of age unable to understand English and consent to participation of child.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Arm; Ellume Home Flu Test and ellume.lab Flu A+B Test Upper respiratory tract samples from participants will be tested with: Ellume Home Flu Test; ellume.lab Flu A+B Test; Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and viral culture.

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.; Diagnostic test: Ellume Home Flu Test; The Ellume Home Flu Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal swab samples.; Diagnostic test: ellume.lab Flu A+B Test; The ellume.lab Flu A+B Test is a rapid 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.; 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.

What is the study measuring?

Primary 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 Ellume Home Flu Test.	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.	1 day
Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (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 intervals.	1 day
Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by Ellume Home Flu Test.	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.	1 day
Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (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 intervals.	1 day
Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza B by Ellume Home Flu Test.	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.	1 day
Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (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 intervals.	1 day
Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza B by Ellume Home Flu Test.	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.	1 day
Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (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 intervals.	1 day

Secondary 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 Ellume Home Flu Test.	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.	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 intervals.	1day
Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by Ellume Home Flu Test.	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.	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 intervals.	1 day
Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by Ellume Home Flu 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 intervals.	1 day
Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by Ellume Home Flu Test.	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.	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 intervals.	1 day
Percent of participants who correctly interpret the result of the Ellume Home Flu Test	Agreement between trained staff and participants. Report as a percentage of participants with 96% confidence limits.	1 day
Scores from questionnaire to assess ease of use, comfort and convenience of the Ellume Home Flu 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 the 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): August 31, 2018
• Primary Completion (Actual): November 16, 2018
• Study Completion (Actual): November 16, 2018

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (Actual): July 23, 2018

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IE-FLU-AUS-1801

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No