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

NCT02767414 | Completed

• 1 other identifier: RESP16001
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Influenza A; Influenza B

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (6)

• 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.

  Day 1

• 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.

  Day 1

• 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.

  Day 1

• 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.

  Day 1

• Percent of participants who correctly interpret result of Respirio Flu Test.

  Day 1

Study Arms (1)

Respirio Flu Test and eLab Flu Test

EXPERIMENTAL

Upper respiratory tract samples from participants will be tested with: Respirio Flu Test; eLab Flu Test; and Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

Device: Respirio Flu Test; Device: eLab Flu Test; Device: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

Interventions

Respirio Flu Test DEVICE

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.

Respirio Flu Test and eLab Flu Test

eLab Flu Test DEVICE

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.

Respirio Flu Test and eLab Flu Test

Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) DEVICE

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.

Respirio Flu Test and eLab Flu Test

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ellume Pty Ltd: lead

Study Sites (7)

Red Hill Doctors Surgery

Brisbane, Queensland, 4059, Australia

Location

Mater Hospital - Brisbane

Brisbane, Queensland, 4101, Australia

Location

Doctors@Carindale

Brisbane, Queensland, 4152, Australia

Location

Capalaba Medical Centre

Redland, Queensland, 4157, Australia

Location

Clinical Trials Centre - University of the Sunshine Coast

Sippy Downs, Queensland, 4556, Australia

Location

Barwon Health - Geelong

Geelong, Victoria, 3220, Australia

Location

The Royal Children's Hospital

Melbourne, Victoria, 3052, Australia

Location

MeSH Terms

Interventions

Reverse Transcriptase Polymerase Chain Reaction

Intervention Hierarchy (Ancestors)

Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Study Officials

• Noel Cranswick

  Australian Paediatric Pharmacology Research Unit, Royal Children's Hospital

  PRINCIPAL INVESTIGATOR

• James Pollard

  Barwon Health - Geelong

  PRINCIPAL INVESTIGATOR

• Paul Griffin

  Mater Hospital - Brisbane

  PRINCIPAL INVESTIGATOR

• Stephen Windley

  Doctors@Carindale

  PRINCIPAL INVESTIGATOR

• Luke Katahanas

  Capalaba Medical Centre

  PRINCIPAL INVESTIGATOR

• Bernardine McKellar

  Red Hill Doctors Surgery

  PRINCIPAL INVESTIGATOR

• Evan Jones

  University of Sunshine Coast Clinical Trials Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 10, 2016
• Study Start: July 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 6, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (7)