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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
25
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.
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.
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.
Paratus Clinical Kanwal Trial Clinic
Kanwal, New South Wales, Australia
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.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
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 ellume.lab Flu A+B Test.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
Time frame: 1 day
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.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
Time frame: 1 day
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.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
Time frame: 1 day
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.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
Time frame: 1 day
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.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
Time frame: 1 day
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.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
Time frame: 1 day
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.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
Time frame: 1 day
Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by Ellume Home Flu Test.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
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 intervals.
Time frame: 1day
Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by Ellume Home Flu Test.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
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 intervals.
Time frame: 1 day
Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by Ellume Home Flu 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 intervals.
Time frame: 1 day
Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by Ellume Home Flu Test.
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Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
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 intervals.
Time frame: 1 day
Percent of participants who correctly interpret the result of the Ellume Home Flu Test
Agreement between trained staff and participants. Report as a percentage of participants with 96% confidence limits.
Time frame: 1 day
Scores from questionnaire to assess ease of use, comfort and convenience of the Ellume Home 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).
Time frame: 1 day
Scores from questionnaire to assess ease of use and convenience of the 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