Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B

NCT02487173 | Completed

• 1 other identifier: RESP15001
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 4

Brief Summary

The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test in detecting Influenza A, when used by subjects, 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 in detecting Influenza B , when used by subjects, as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).
• assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza A+B Test in detecting Influenza A;
• assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza A+B Test in detecting Influenza B;
• evaluate the correct interpretation of the Respirio Flu Test results by subjects with Influenza-like illness symptoms;
• evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the Respirio Flu Test;
• evaluate the subjects' comprehension of the Respirio Flu Test labelling; and
• establish the minimum sample weight required to achieve a result with the Respirio Flu Test.

Conditions

Influenza A; Influenza B

Outcome Measures

Primary Outcomes (2)

• Of participants positive for influenza A by ReverseTranscriptase 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 95% 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 95% confidence limits.

  Day 1

Secondary Outcomes (9)

• 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 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

• Percent of participants positive for influenza A by Sofia® Influenza A+B Test and Respirio Flu Test.

  Day 1

• Percent of participants negative for influenza B by Sofia® Influenza A+B Test and Respirio Flu Test.

  Day 1

• Combine positive and negative agreement of Respirio Flu Test and Sofia® Influenza A+B Test to establish overall agreement. Report as a percentage of participants with 95% confidence limits.

  Day 1

Study Arms (1)

Respirio Flu Test

EXPERIMENTAL

Upper respiratory tract samples from participants will be tested with: * Respirio Flu Test * Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) * Sofia® Influenza A+B Fluorescent Immunoassay (FIA)

Device: Respirio Flu Test; Device: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); Device: Sofia® Influenza A+B Fluorescent Immunoassay (FIA)

Interventions

Respirio Flu Test DEVICE

The Respirio Flu Test is a rapid 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

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

Sofia® Influenza A+B Fluorescent Immunoassay (FIA) DEVICE

Sofia® Influenza A+B Fluorescent Immunoassay (FIA) employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash samples taken directly from symptomatic patients.

Respirio 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;
• ≤ 72 hours 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 in 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;
• Subject (or parent/legal guardian) residing at the same residential address as a subject currently enrolled in this study.

Sponsors & Collaborators

• Ellume Pty Ltd: lead

Study Sites (4)

Taringa 7 Day Medical Practice

Brisbane, Queensland, 4068, Australia

Location

Graceville Medical

Brisbane, Queensland, 4075, Australia

Location

Inala Primary Care

Brisbane, Queensland, 4077, Australia

Location

Limestone Medical Centre

Ipswich, Queensland, 4305, 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 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: June 26, 2015
• First Posted: July 1, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 15, 2016

Record last verified: 2016-07

Locations

AU (4)