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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02767414




Registration number
NCT02767414
Ethics application status
Date submitted
6/05/2016
Date registered
10/05/2016
Date last updated
6/12/2016

Titles & IDs
Public title
Validation of the Ellume® Respirio Flu Test and the Ellume® eLab Flu Test for the Rapid Identification of Influenza A/B
Scientific title
A Prospective Multi-centre Study of the Ellume® Respirio Flu Test and the Ellume® eLab Flu Test Performance Versus Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) for the Rapid Detection of Influenza A/B
Secondary ID [1] 0 0
RESP16001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza A 0 0
Influenza B 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Respirio Flu Test
Treatment: Devices - eLab Flu Test
Treatment: Devices - Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

Experimental: Respirio Flu Test and eLab Flu Test - Upper respiratory tract samples from participants will be tested with:
Respirio Flu Test; eLab Flu Test; and Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)


Treatment: Devices: Respirio Flu Test
The Respirio Flu Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal secretions. The Respirio Flu Test is designed to be simple to use and generates a result within 20 minutes.

Treatment: Devices: eLab Flu Test
The eLab Flu 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 nasopharyngeal swab samples. The eLab Flu Test generates a result within 10 minutes.

Treatment: Devices: 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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by Respirio Flu Test. - Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Timepoint [1] 0 0
Day 1
Primary outcome [2] 0 0
Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by eLab Flu Test. - Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Timepoint [2] 0 0
Day 1
Primary outcome [3] 0 0
Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by Respirio Flu Test. - Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Timepoint [3] 0 0
Day 1
Primary outcome [4] 0 0
Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by eLab Flu Test. - Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Timepoint [4] 0 0
Day 1
Secondary outcome [1] 0 0
Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza B by Respirio Flu Test. - Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Timepoint [1] 0 0
Day 1
Secondary outcome [2] 0 0
Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza B by eLab Flu Test. - Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Timepoint [2] 0 0
Day 1
Secondary outcome [3] 0 0
Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza B by Respirio Flu Test. - Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Timepoint [3] 0 0
Day 1
Secondary outcome [4] 0 0
Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza B by eLab Flu Test. - Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Timepoint [4] 0 0
Day 1
Secondary outcome [5] 0 0
Percent of participants who correctly interpret result of Respirio Flu Test. - Agreement between trained staff and participants. Report as a percentage of participants with 95% confidence limits.
Timepoint [5] 0 0
Day 1
Secondary outcome [6] 0 0
Scores from questionnaire to assess ease of use, comfort and convenience of Respirio 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).
Timepoint [6] 0 0
Day 1

Eligibility
Key inclusion criteria
- Male and female subjects aged = 1 year;

- Rhinorrhea;

- = 5 days from onset of influenza-like illness symptoms;

- Subject (or parent/legal guardian) capable and willing to give informed
consent/assent;

- Subject (or parent/legal guardian) able to read and write English.
Minimum age
1 Year
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Has undergone treatment with antivirals within the previous 7 days;

- Has been vaccinated by means of an influenza nasal spray/mist vaccine within the
previous 7 days;

- Recent craniofacial injury or surgery, including surgery to correct deviation of the
nasal septum, within the previous 6 months;

- Currently enrolled in another clinical trial or used any investigational device within
90 days preceding informed consent;

- Has had prior exposure to the Respirio Flu Test or eLab Flu Test.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Red Hill Doctors Surgery - Brisbane
Recruitment hospital [2] 0 0
Mater Hospital - Brisbane - Brisbane
Recruitment hospital [3] 0 0
Doctors@Carindale - Brisbane
Recruitment hospital [4] 0 0
Capalaba Medical Centre - Redland
Recruitment hospital [5] 0 0
Clinical Trials Centre - University of the Sunshine Coast - Sippy Downs
Recruitment hospital [6] 0 0
Barwon Health - Geelong - Geelong
Recruitment hospital [7] 0 0
The Royal Children's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
4059 - Brisbane
Recruitment postcode(s) [2] 0 0
4101 - Brisbane
Recruitment postcode(s) [3] 0 0
4152 - Brisbane
Recruitment postcode(s) [4] 0 0
4157 - Redland
Recruitment postcode(s) [5] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [6] 0 0
3220 - Geelong
Recruitment postcode(s) [7] 0 0
3052 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ellume Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary purpose of this study is to validate the sensitivity and specificity of the
Respirio Flu Test and the eLab Flu Test in detecting Influenza A as compared to the gold
standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).

The secondary aims are to:

Validate the sensitivity and specificity of the Respirio Flu Test and the eLab Flu Test in
detecting Influenza B as compared to the gold standard for detection, Reverse Transcriptase
Polymerase Chain Reaction (RT-PCR); Evaluate the correct interpretation of the Respirio Flu
Test by subjects with influenza-like symptoms; Evaluate the subjects' satisfaction with the
convenience, comfort and ease of use of the Respirio Flu Test.
Trial website
https://clinicaltrials.gov/show/NCT02767414
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Noel Cranswick
Address 0 0
Australian Paediatric Pharmacology Research Unit, Royal Children's Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications