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Completed

NCT Number: NCT03595358

Ellume·Lab Flu A+B Test and the Ellume Home Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction

The primary purpose of the study is to validate the sensitivity and specificity of the Ellume Home Flu 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)

Secondary aims are to:

Validate the sensitivity and specificity of the Ellume Home Flu Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture; Evaluate the participant's satisfaction with the convenience and ease of use of the Ellume Home Flu Test; Evaluate the participant's interpretation of the Ellume Home Flu Test results compared to the interpretation by site staff; Evaluate the operator's satisfaction and 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

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Paratus Clinical Kanwal Trial Clinic

Kanwal, New South Wales, 2559, Australia

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 ≥ 2 years; and
  • Fever ≥ 37.8° C (100° F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8° C or feeling feverish within 24 hours of presentation; and
  • Rhinorrhea; and
  • ≤ 72 hours from onset of ILI symptoms; 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 < 2 years.
  • 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 used any investigational device within 30 days preceding informed consent.
  • Participants previously enrolled in IE-FLU-AUS-1801;
  • Participants 18 years of age or older unable to understand English and consent to participation;
  • Parent/legal guardian of participants < 18 years of age unable to understand English and consent to participation of child.

Treatment and study plan

Ellume Home Flu Test

Diagnostic Test

The Ellume Home Flu Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal swab samples.

ellume.lab Flu A+B Test

Diagnostic Test

The ellume.lab Flu A+B Test is a rapid 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.

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 Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by Ellume Home Flu Test.

    Time frame: 1 day

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

  2. Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (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 intervals.

  3. Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by Ellume Home Flu Test.

    Time frame: 1 day

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

  4. Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (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 intervals.

  5. Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza B by Ellume Home Flu Test.

    Time frame: 1 day

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

  6. Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (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 intervals.

  7. Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza B by Ellume Home Flu Test.

    Time frame: 1 day

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

  8. Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (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 intervals.

Secondary outcomes

  1. Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by Ellume Home Flu Test.

    Time frame: 1 day

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

  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: 1day

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

  3. Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by Ellume Home Flu Test.

    Time frame: 1 day

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

  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 intervals.

  5. Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by Ellume Home Flu 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 intervals.

  7. Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by Ellume Home Flu Test.

    Time frame: 1 day

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

  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 intervals.

  9. Percent of participants who correctly interpret the result of the Ellume Home Flu Test

    Time frame: 1 day

    Agreement between trained staff and participants. Report as a percentage of participants with 96% confidence limits.

  10. Scores from questionnaire to assess ease of use, comfort and convenience of the Ellume Home Flu 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 the 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 the Ellume Home Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 23, 2018
Registry last updated
Jun 15, 2023

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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