Influenza
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTEllume 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.
DIAGNOSTIC_TESTellume.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.
DIAGNOSTIC_TESTReverse 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_TESTViral 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.
Sponsors
Ellume Pty Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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.
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 Ellume Home Flu Test. | 1 day | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals. |
| 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. | 1 day | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals. |
| 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. | 1 day | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals. |
| 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. | 1 day | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals. |
| 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. | 1 day | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals. |
| 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. | 1 day | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals. |
| 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. | 1 day | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals. |
| 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. | 1 day | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of participants who correctly interpret the result of the Ellume Home Flu Test | 1 day | Agreement between trained staff and participants. Report as a percentage of participants with 96% confidence limits. |
| Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by Ellume Home Flu Test. | 1 day | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals. |
| Scores from questionnaire to assess ease of use and convenience of the ellume.lab Flu A+B Test. | 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). |
| Scores from questionnaire to assess ease of use, comfort and convenience of the Ellume Home Flu Test. | 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). |
| Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by ellume.lab Flu A+B Test. | 1day | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals. |
| Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by Ellume Home Flu Test. | 1 day | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals. |
| Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by ellume.lab Flu A+B Test. | 1 day | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals. |
| Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by Ellume Home Flu Test. | 1 day | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits. |
| Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by ellume.lab Flu A+B Test. | 1 day | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals. |
| Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by Ellume Home Flu Test. | 1 day | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals. |
| Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by ellume.lab Flu A+B Test. | 1 day | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals. |
Countries
Australia
Outcome results
None listed