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Completed

NCT Number: NCT02767414

Validation of the Ellume® Respirio Flu Test and the Ellume® eLab Flu Test for the Rapid Identification of Influenza A/B

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.

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Key information

Conditions

Influenza A Influenza B

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Doctors@Carindale, Brisbane, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Respirio Flu Test

Device

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

Device

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)

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.

Primary outcomes

  1. 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

    Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.

  2. 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

    Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.

  3. 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

    Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.

  4. 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

    Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.

Secondary outcomes

  1. 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

    Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.

  2. 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

    Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.

  3. 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

    Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.

  4. 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

    Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.

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

    Time frame: Day 1

    Agreement between trained staff and participants. Report as a percentage of participants with 95% confidence limits.

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

    Time frame: Day 1

    The ease of use questionnaire will provide total number of responses to each question and the percentage of participants selecting each response (on a 5 point Likert scale).

Sponsors and collaborators

Lead sponsor

Ellume Pty Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 10, 2016
Registry last updated
Dec 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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