Overview

This trial has been completed.

Conditions influenza a, influenza b
Treatments respirio flu test, elab flu test, reverse transcriptase polymerase chain reaction (rt-pcr)
Sponsor Ellume Pty Ltd
Start date July 2016
End date October 2016
Trial size 1500 participants
Trial identifier NCT02767414, RESP16001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(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)
respirio flu test
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.
elab flu test
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.
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.

Primary Outcomes

Measure
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.
time frame: 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.
time frame: 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.
time frame: 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.
time frame: 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.
time frame: 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.
time frame: 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.
time frame: 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.
time frame: Day 1
Percent of participants who correctly interpret result of Respirio Flu Test.
time frame: Day 1
Scores from questionnaire to assess ease of use, comfort and convenience of Respirio Flu Test.
time frame: Day 1

Eligibility Criteria

Male or female participants at least 1 year old.

Inclusion Criteria: - 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. 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 or eLab Flu Test.

Additional Information

Official title A Prospective Multi-centre Study of the Ellume® Respirio Flu Test and the Ellume® eLab Flu Test Performance Versus Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) for the Rapid Detection of Influenza A/B
Principal investigator Noel Cranswick
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Ellume Pty Ltd.