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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
381
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.
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) 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.
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.
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
Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by iTreat Flu A+B Test.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Time frame: 1 day
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 limits.
Time frame: 1 day
Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by iTreat Flu A+B Test.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Time frame: 1 day
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 limits.
Time frame: 1 day
Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by iTreat Flu A+B Test.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Time frame: 1 day
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 limits.
Time frame: 1 day
Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by iTreat Flu A+B Test.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Time frame: 1 day
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 limits.
Time frame: 1 day
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.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Time frame: 1 day
Of participants positive for influenza A by 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 limits.
Time frame: 1 day
Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by iTreat Flu A+B Test.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Time frame: 1 day
Of participants negative for influenza A by 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 limits.
Time frame: 1 day
Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by iTreat Flu A+B Test.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Time frame: 1 day
Of participants positive for influenza B by 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 limits.
Time frame: 1 day
Of participants negative for influenza B by RT-PCR, the percentage who are negative for influenza B by iTreat Flu A+B Test.
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Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Time frame: 1 day
Of participants negative for influenza B by 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 limits.
Time frame: 1 day
Percent of participants who correctly interpret result of iTreat Flu A+B Test.
Agreement between trained staff and participants. Report as a percentage of participants with 95% confidence limits
Time frame: 1 day
Scores from questionnaire to assess ease of use, comfort and convenience of iTreat 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).
Time frame: 1 day
Scores from questionnaire to assess ease of use and convenience of 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).
Time frame: 1 day