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

• ClinicalTrials.gov Identifier: NCT03248960
• Recruitment Status: Completed
• First Posted: August 15, 2017
• Last Update Posted: February 1, 2018
• Sponsor: Ellume Pty Ltd
• Information provided by (Responsible Party): Ellume Pty Ltd

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Influenza	Diagnostic Test: iTreat Flu A+B Test; Diagnostic Test: ellume.lab Flu A+B Test; Diagnostic Test: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); Diagnostic Test: Viral culture	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 381 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official 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.
• Actual Study Start Date: July 27, 2017
• Actual Primary Completion Date: December 23, 2017
• Actual Study Completion Date: December 23, 2017

Arms and Interventions

Arm

Intervention/treatment

Experimental: iTreat Flu A+B Test and ellume.lab Flu A+B Test; Upper respiratory tract samples from participants will be tested with: iTreat Flu A+B Test; ellume.lab Flu A+B Test; Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); and viral culture.

Diagnostic Test: iTreat Flu A+B 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.; Diagnostic Test: ellume.lab Flu A+B 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.; Diagnostic Test: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); 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.; Diagnostic Test: Viral culture; 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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).

Eligibility Criteria

• Ages Eligible for Study: 1 Year and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Australia, Australian Capital Territory

Ochre Health Medical Centre Casey

Casey, Australian Capital Territory, Australia, 2913

Australia, New South Wales

Paratus Clinical Blacktown Trial Clinic

Blacktown, New South Wales, Australia, 2148

Paratus Clinical Kanwal Trial Clinic

Kanwal, New South Wales, Australia, 2559

Australia, Queensland

Coastal Family Health

Buddina, Queensland, Australia, 4575

Morayfield Family Doctors

Morayfield, Queensland, Australia, 4506

USC Health Clinics

Sippy Downs, Queensland, Australia, 4556

Griffith University Clinical Trial Unit

Southport, Queensland, Australia, 4125

Australia, Victoria

Emeritus Research

Malvern East, Victoria, Australia, 3145

Sponsors and Collaborators

Ellume Pty Ltd

More Information

• Responsible Party: Ellume Pty Ltd
• ClinicalTrials.gov Identifier: NCT03248960
• Other Study ID Numbers: iE-FLU-AUS-1701
• First Posted: August 15, 2017
• Last Update Posted: February 1, 2018
• Last Verified: January 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No