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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03595358
• Other study ID #: IE-FLU-AUS-1801
• Status: Completed
• Phase: N/A
• Start date: August 31, 2018
• Est. completion date: November 16, 2018

Study information

• Verified date: June 2023
• Source: Ellume Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 16, 2018
• Est. primary completion date: November 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Influenza

Intervention

Diagnostic Test:
• Ellume Home Flu 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
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)
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 Kanwal Trial Clinic	Kanwal	New South Wales

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 Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by Ellume Home Flu Test.	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.	1 day
Primary	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.	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.	1 day
Primary	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.	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.	1 day
Primary	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.	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.	1 day
Primary	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.	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.	1 day
Primary	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.	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.	1 day
Primary	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.	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.	1 day
Primary	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.	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.	1 day
Secondary	Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by Ellume Home Flu Test.	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.	1 day
Secondary	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 intervals.	1day
Secondary	Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by Ellume Home Flu Test.	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.	1 day
Secondary	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 intervals.	1 day
Secondary	Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by Ellume Home Flu 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 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 intervals.	1 day
Secondary	Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by Ellume Home Flu Test.	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.	1 day
Secondary	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 intervals.	1 day
Secondary	Percent of participants who correctly interpret the result of the Ellume Home Flu Test	Agreement between trained staff and participants. Report as a percentage of participants with 96% confidence limits.	1 day
Secondary	Scores from questionnaire to assess ease of use, comfort and convenience of the Ellume Home Flu 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 the 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