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

Information source: Ellume Pty Ltd
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza A; Influenza B

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

Phase: N/A

Status: Not yet recruiting

Sponsored by: Ellume Pty Ltd

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.

Clinical Details

Official title: A Prospective Multi-Centre Study of the Respirio Flu Test Performance Versus Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and Sofia« Influenza A+B Fluorescent Immunoassay (FIA) for the Rapid Detection of Influenza A/B

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome:

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.

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.

Secondary outcome:

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.

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.

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

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

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.

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

Scores from questionnaire to assess ease of use, comfort and convenience of Respirio Flu Test.

Percent of participants correctly determining eligibility and conditions for use of Respirio Flu Test from scores on a label comprehension questionnaire.

Weight of sample deposited in Respirio Flu Test.

Eligibility

Minimum age: 1 Year. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female subjects aged Ôëą 1 year;

- Rhinorrhea;

- ÔëĄ 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.

Locations and Contacts

Additional Information

Starting date: August 2015
Last updated: June 30, 2015

Page last updated: August 20, 2015

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