Influenza A, Influenza B
Conditions
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.
Interventions
DEVICERespirio 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.
DEVICEeLab 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.
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.
Sponsors
Ellume Pty Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Day 1 | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits. |
| 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. | Day 1 | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits. |
| 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. | Day 1 | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits. |
| 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. | Day 1 | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of participants who correctly interpret result of Respirio Flu Test. | Day 1 | Agreement between trained staff and participants. Report as a percentage of participants with 95% confidence limits. |
| 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. | Day 1 | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits. |
| Scores from questionnaire to assess ease of use, comfort and convenience of Respirio Flu Test. | Day 1 | 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). |
| 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. | Day 1 | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits. |
| 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. | Day 1 | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits. |
| 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. | Day 1 | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits. |
Countries
Australia
Outcome results
None listed