Ellume·Lab Flu A+B Test and the Ellume Home Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction
- Conditions
- Influenza
- Registration Number
- NCT03595358
- Lead Sponsor
- Ellume Pty Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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. 1 day Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
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. 1 day Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
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. 1 day Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
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. 1 day Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
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. 1 day Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
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. 1 day Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
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. 1 day Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
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. 1 day Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
- Secondary Outcome Measures
Name Time Method Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by ellume.lab Flu A+B Test. 1 day Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by ellume.lab Flu A+B Test. 1day Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by ellume.lab Flu A+B Test. 1 day Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by ellume.lab Flu A+B Test. 1 day Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
Scores from questionnaire to assess ease of use, comfort and convenience of the Ellume Home Flu Test. 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).
Scores from questionnaire to assess ease of use and convenience of the ellume.lab Flu A+B Test. 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).
Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by Ellume Home Flu Test. 1 day Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by Ellume Home Flu Test. 1 day Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by Ellume Home Flu Test. 1 day Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by Ellume Home Flu Test. 1 day Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Percent of participants who correctly interpret the result of the Ellume Home Flu Test 1 day Agreement between trained staff and participants. Report as a percentage of participants with 96% confidence limits.
Trial Locations
- Locations (1)
Paratus Clinical Kanwal Trial Clinic
🇦🇺Kanwal, New South Wales, Australia
Paratus Clinical Kanwal Trial Clinic🇦🇺Kanwal, New South Wales, Australia