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

NCT ID: NCT02487173

Last Updated: 2016-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2015-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Respirio Flu Test

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)

Group Type: EXPERIMENTAL

Respirio Flu Test

Intervention Type: 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.

Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

Intervention Type: 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.

Sofia® Influenza A+B Fluorescent Immunoassay (FIA)

Intervention Type: 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.

Interventions

Respirio Flu Test

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Sofia® Influenza A+B Fluorescent Immunoassay (FIA)

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

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

• Minimum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ellume Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taringa 7 Day Medical Practice

Brisbane, Queensland, Australia

Graceville Medical

Brisbane, Queensland, Australia

Inala Primary Care

Brisbane, Queensland, Australia

Limestone Medical Centre

Ipswich, Queensland, Australia

Countries

Australia

Other Identifiers

RESP15001

Identifier Type: -

Identifier Source: org_study_id