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.
| Registry | NCT03248960 |
|---|
| Status | Completed |
|---|
| Phase | Not applicable |
|---|
| Study type | Interventional; na, single group, masking: none, diagnostic |
|---|
| Enrollment | 381 (Actual) |
|---|
| Sponsor | Ellume Pty Ltd (Industry) |
|---|
| Conditions | Influenza |
|---|
| Interventions | iTreat Flu A+B Test, ellume.lab Flu A+B Test, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Viral culture (Diagnostic test) |
|---|
| Dates | start 2017-07-27, primary completion 2017-12-23, completion 2017-12-23, first posted 2017-08-15, last updated 2018-02-01 |
|---|
| Locations | 8 sites in Australia |
|---|
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Influenza All trials of iTreat Flu A+B Test All trials of ellume.lab Flu A+B Test
-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.
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| iTreat Flu A+B Test and ellume.lab Flu A+B Test | Experimental | Diagnostic Test: iTreat Flu A+B Test; Diagnostic Test: ellume.lab Flu A+B Test; Diagnostic Test: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); Diagnostic Test: Viral culture | Upper respiratory tract samples from participants will be tested with:
iTreat Flu A+B Test; ellume.lab Flu A+B Test; Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); and viral culture. |
- iTreat Flu A+B Test (Diagnostic 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 (Diagnostic 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) (Diagnostic test): 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 (Diagnostic test): 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.
+Outcome measures
Primary outcomes
- Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by iTreat Flu A+B Test. [1 day]: Establish sensitivity against a gold standard. 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.lab Flu A+B Test. [1 day]: Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
- Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by iTreat Flu A+B Test. [1 day]: Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
- 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 limits.
- Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by iTreat Flu A+B 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 limits.
- Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by iTreat Flu A+B Test. [1 day]: Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
- 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 limits.
Secondary outcomes
- 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. [1 day]: Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
- Of participants positive for influenza A by 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 limits.
- Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by iTreat Flu A+B Test. [1 day]: Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
- Of participants negative for influenza A by 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 limits.
- Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by iTreat Flu A+B 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 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 limits.
- Of participants negative for influenza B by RT-PCR, the percentage who are negative for influenza B by iTreat Flu A+B Test. [1 day]: Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
- Of participants negative for influenza B by 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 limits.
- Percent of participants who correctly interpret result of iTreat Flu A+B Test. [1 day]: Agreement between trained staff and participants. Report as a percentage of participants with 95% confidence limits
- Scores from questionnaire to assess ease of use, comfort and convenience of iTreat 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 and convenience of 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).
+Eligibility
Sex: All, ages: 1 Year to any
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.
+Locations (8)
| Facility | City | Country | Status |
|---|
| Ochre Health Medical Centre Casey | Casey, Australian Capital Territory | Australia | |
| Paratus Clinical Blacktown Trial Clinic | Blacktown, New South Wales | Australia | |
| Paratus Clinical Kanwal Trial Clinic | Kanwal, New South Wales | Australia | |
| Coastal Family Health | Buddina, Queensland | Australia | |
| Morayfield Family Doctors | Morayfield, Queensland | Australia | |
| USC Health Clinics | Sippy Downs, Queensland | Australia | |
| Griffith University Clinical Trial Unit | Southport, Queensland | Australia | |
| Emeritus Research | Malvern East, Victoria | Australia | |