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

Not Applicable

Completed

• Conditions: Influenza

• Registration Number: NCT03248960
• Lead Sponsor: Ellume Pty Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-27
• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-08-10
• Study First Posted: 2017-08-15
• Primary Completion: 2017-12-23
• Study Completion: 2017-12-23
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 381

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by iTreat Flu A+B Test.	1 day	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Of participants positive for influenza A by viral culture, 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 limits.
Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by iTreat Flu A+B Test.	1 day	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
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 limits.
Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by iTreat Flu A+B Test.	1 day	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
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 limits.
Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by iTreat Flu A+B Test.	1 day	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
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 limits.

Secondary 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 iTreat Flu A+B Test.	1 day	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Of participants positive for influenza A by 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 limits.
Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by iTreat Flu A+B Test.	1 day	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Of participants negative for influenza A by 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 limits.
Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by iTreat Flu A+B Test.	1 day	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Of participants positive for influenza B by 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 limits.
Of participants negative for influenza B by RT-PCR, the percentage who are negative for influenza B by iTreat Flu A+B Test.	1 day	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Of participants negative for influenza B by 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 limits.
Percent of participants who correctly interpret result of iTreat Flu A+B Test.	1 day	Agreement between trained staff and participants. Report as a percentage of participants with 95% confidence limits
Scores from questionnaire to assess ease of use, comfort and convenience of iTreat 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).
Scores from questionnaire to assess ease of use and convenience of 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).

Trial Locations

Locations (8)

Ochre Health Medical Centre Casey; 🇦🇺 Casey, Australian Capital Territory, Australia

Paratus Clinical Blacktown Trial Clinic; 🇦🇺 Blacktown, New South Wales, Australia

Paratus Clinical Kanwal Trial Clinic; 🇦🇺 Kanwal, New South Wales, Australia

Coastal Family Health; 🇦🇺 Buddina, Queensland, Australia

Morayfield Family Doctors; 🇦🇺 Morayfield, Queensland, Australia

USC Health Clinics; 🇦🇺 Sippy Downs, Queensland, Australia

Griffith University Clinical Trial Unit; 🇦🇺 Southport, Queensland, Australia

Emeritus Research; 🇦🇺 Malvern East, Victoria, Australia