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

Influenza Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03248960
• Other study ID #: iE-FLU-AUS-1701
• Status: Completed
• Phase: N/A
• First received: August 10, 2017
• Last updated: January 30, 2018
• Start date: July 27, 2017
• Est. completion date: December 23, 2017

Study information

• Verified date: January 2018
• Source: Ellume Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 381
• Est. completion date: December 23, 2017
• Est. primary completion date: December 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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.

Related Conditions & MeSH terms

• Influenza

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Australia	Paratus Clinical Blacktown Trial Clinic	Blacktown	New South Wales
Australia	Coastal Family Health	Buddina	Queensland
Australia	Ochre Health Medical Centre Casey	Casey	Australian Capital Territory
Australia	Paratus Clinical Kanwal Trial Clinic	Kanwal	New South Wales
Australia	Emeritus Research	Malvern East	Victoria
Australia	Morayfield Family Doctors	Morayfield	Queensland
Australia	USC Health Clinics	Sippy Downs	Queensland
Australia	Griffith University Clinical Trial Unit	Southport	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Ellume Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

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