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Completed

NCT Number: NCT03248960

Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.

The primary purpose of this study is to validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture.

The secondary aims are to:

Validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).

Evaluate the correct interpretation of the iTreat Flu A+B Test by subjects with influenza-like symptoms.

Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the iTreat Flu A+B Test.

Evaluate the operators' satisfaction with the ease of use of the ellume.lab Flu A+B Test.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ochre Health Medical Centre Casey, Casey, Australian Capital Territory, 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 participants aged ≥ 18 years: iTreat Flu A+B Test and ellume.lab Flu A+B Test OR aged ≥ 1 and <18 years: ellume.lab Flu A+B Test only; and
  • Fever ≥ 37.8°C (100°F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8°C (100°F) or feeling feverish within 24 hours of presentation; and
  • Rhonorrhea or blocked nose; and
  • Participant (or parent/legal guardian) capable and willing to give informed consent/assent; and
  • Participant (or parent/legal guardian) able to read and write in English.

Exclusion criteria

  • Participants aged <1 year.
  • Participants who have undergone treatment with Tamiflu (oseltamivir), Relenza (zanamivir) or Symmetral (amantadine) within the previous 7 days.
  • Participants who have been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.
  • Participants who have had a nose bleed within the past 30 days.
  • Participants who have had recent craniofacial injury or surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months.
  • Participants currently enrolled in another clinical trial or have used any investigational device within 30 days preceding informed consent.
  • Participants 18 years of age or older unable to understand English and consent to participation.
  • Parent/legal guardian of Paticipants <18 years of age unable to understand English and consent to participation of child.
  • Participants who have had prior exposure to iTreat Flu A+B Test.
  • participants who have been previously enrolled in the iE-FLU-AUS-1701 study.

Treatment and study plan

iTreat Flu A+B Test

Diagnostic Test

The iTreat Flu A+B Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal swab samples. The iTreat Flu A+B Test is designed to be simple to use and generates a result within 15 minutes.

ellume.lab Flu A+B Test

Diagnostic Test

The ellume.lab Flu A+B 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 nasal swab samples. The ellume.lab Flu A+B Test generates a result within 10 minutes.

Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

Diagnostic Test

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.

Viral culture

Diagnostic Test

Nasopharyngeal samples will be inoculated into appropriate culture media for influenza viral culture. In this test, the virus is actually grown and further identified in the laboratory as influenza A or B.

Primary outcomes

  1. Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by iTreat Flu A+B Test.

    Time frame: 1 day

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

  2. Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by ellume.lab Flu A+B Test.

    Time frame: 1 day

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

  3. Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by iTreat Flu A+B Test.

    Time frame: 1 day

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

  4. Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by ellume.lab Flu A+B Test.

    Time frame: 1 day

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

  5. Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by iTreat Flu A+B Test.

    Time frame: 1 day

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

  6. Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by ellume.lab Flu A+B Test.

    Time frame: 1 day

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

  7. Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by iTreat Flu A+B Test.

    Time frame: 1 day

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

  8. Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by ellume.lab Flu A+B Test.

    Time frame: 1 day

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

Secondary 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 iTreat Flu A+B Test.

    Time frame: 1 day

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

  2. Of participants positive for influenza A by RT-PCR, the percentage who are positive for influenza A by ellume.lab Flu A+B Test.

    Time frame: 1 day

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

  3. Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by iTreat Flu A+B Test.

    Time frame: 1 day

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

  4. Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by ellume.lab Flu A+B Test.

    Time frame: 1 day

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

  5. Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by iTreat Flu A+B Test.

    Time frame: 1 day

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

  6. Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by ellume.lab Flu A+B Test.

    Time frame: 1 day

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

  7. Of participants negative for influenza B by RT-PCR, the percentage who are negative for influenza B by iTreat Flu A+B Test.

    Time frame: 1 day

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

  8. Of participants negative for influenza B by RT-PCR, the percentage who are negative for influenza B by ellume.lab Flu A+B Test.

    Time frame: 1 day

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

  9. Percent of participants who correctly interpret result of iTreat Flu A+B Test.

    Time frame: 1 day

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

  10. Scores from questionnaire to assess ease of use, comfort and convenience of iTreat Flu A+B Test.

    Time frame: 1 day

    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).

  11. Scores from questionnaire to assess ease of use and convenience of ellume.lab Flu A+B Test.

    Time frame: 1 day

    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.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 15, 2017
Registry last updated
Feb 1, 2018

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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