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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm | Experimental | Ellume Home Flu Test and ellume.lab Flu A+B Test Upper respiratory tract samples from participants will be tested with: Ellume Home Flu Test; ellume.lab Flu A+B Test; Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and viral culture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ellume Home Flu Test | Diagnostic 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paratus Clinical Kanwal Trial Clinic | Kanwal | New South Wales | 2559 | Australia |
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| ellume.lab Flu A+B Test | Diagnostic 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. |
|
| 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. |
|
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals. |
| 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. | 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. | 1 day |
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals. |
| 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. | 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. | 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. | 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. | 1 day |
| Of participants negative for influenza B by viral culture, 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. | 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. | 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. | 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). | 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). | 1 day |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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