Clinical trial NCT02487173: Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza A
Influenza B
Lead sponsor: Ellume Pty Ltd
Sponsor class: INDUSTRY
First posted: 2015-07-01
Enrollment: 83
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: 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.
timeFrame: Day 1
measure: 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.
timeFrame: Day 1
Secondary outcomes:
measure: 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.
timeFrame: Day 1
measure: 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.
timeFrame: Day 1
measure: Percent of participants positive for influenza A by Sofia® Influenza A+B Test and Respirio Flu Test.
timeFrame: Day 1
measure: Percent of participants negative for influenza B by Sofia® Influenza A+B Test and Respirio Flu Test.
timeFrame: Day 1
measure: 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.
timeFrame: Day 1
measure: Percent of participants who correctly interpret result of Respirio Flu Test.
timeFrame: Day 1
measure: Scores from questionnaire to assess ease of use, comfort and convenience of Respirio Flu Test.
timeFrame: Day 1
measure: Percent of participants correctly determining eligibility and conditions for use of Respirio Flu Test from scores on a label comprehension questionnaire.
timeFrame: Day 1
measure: Weight of sample deposited in Respirio Flu Test.
timeFrame: Day 1
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Taringa 7 Day Medical Practice
state: Queensland
city: Brisbane
country: Australia
facility: Graceville Medical
state: Queensland
city: Brisbane
country: Australia
facility: Inala Primary Care
state: Queensland
city: Ipswich
country: Australia
facility: Limestone Medical Centre
state: Queensland
Study officials:
References: