Validation of the Ellume® Respirio Flu Test and the Ellume® eLab Flu Test for the Rapid Identification of Influenza A/B

Influenza A Clinical Trial

Official title:

A Prospective Multi-centre Study of the Ellume® Respirio Flu Test and the Ellume® eLab Flu Test Performance Versus Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) for the Rapid Detection of Influenza A/B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02767414
• Other study ID #: RESP16001
• Status: Completed
• Phase: N/A
• First received: May 6, 2016
• Last updated: December 4, 2016
• Start date: July 2016
• Est. completion date: October 2016

Study information

• Verified date: December 2016
• Source: Ellume Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test and the eLab Flu Test in detecting Influenza A as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

• Male and female subjects aged = 1 year;

• 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 undergone treatment with antivirals within the previous 7 days;

• 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Influenza A
• Influenza B
• Influenza, Human

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Australia	Doctors@Carindale	Brisbane	Queensland
Australia	Mater Hospital - Brisbane	Brisbane	Queensland
Australia	Red Hill Doctors Surgery	Brisbane	Queensland
Australia	Barwon Health - Geelong	Geelong	Victoria
Australia	The Royal Children's Hospital	Melbourne	Victoria
Australia	Capalaba Medical Centre	Redland	Queensland
Australia	Clinical Trials Centre - University of the Sunshine Coast	Sippy Downs	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Ellume Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by Respirio Flu Test.	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.	Day 1	No
Primary	Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by eLab Flu Test.	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.	Day 1	No
Primary	Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by Respirio Flu Test.	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.	Day 1	No
Primary	Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by eLab Flu Test.	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.	Day 1	No
Secondary	Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza B by Respirio Flu Test.	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.	Day 1	No
Secondary	Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza B by eLab Flu Test.	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.	Day 1	No
Secondary	Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza B by Respirio Flu Test.	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.	Day 1	No
Secondary	Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza B by eLab Flu Test.	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.	Day 1	No
Secondary	Percent of participants who correctly interpret result of Respirio Flu Test.	Agreement between trained staff and participants. Report as a percentage of participants with 95% confidence limits.	Day 1	No
Secondary	Scores from questionnaire to assess ease of use, comfort and convenience of Respirio 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).	Day 1	No