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The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test and the eLab Flu Test in detecting Influenza A as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).
The secondary aims are to:
Validate the sensitivity and specificity of the Respirio Flu Test and the eLab Flu Test in detecting Influenza B as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); Evaluate the correct interpretation of the Respirio Flu Test by subjects with influenza-like symptoms; Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the Respirio Flu Test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Respirio Flu Test and eLab Flu Test | Experimental | Upper respiratory tract samples from participants will be tested with: Respirio Flu Test; eLab Flu Test; and Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respirio Flu Test | Device | The Respirio Flu Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal secretions. The Respirio Flu Test is designed to be simple to use and generates a result within 20 minutes. |
| 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 Respirio Flu Test. | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits. | Day 1 |
| Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by eLab Flu Test. | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits. | Day 1 |
| Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by Respirio Flu Test. | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits. | Day 1 |
| Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by eLab Flu Test. | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza B by Respirio Flu Test. | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits. | Day 1 |
| Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza B by eLab Flu Test. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noel Cranswick | Australian Paediatric Pharmacology Research Unit, Royal Children's Hospital | Principal Investigator |
| James Pollard | Barwon Health - Geelong | Principal Investigator |
| Paul Griffin | Mater Hospital - Brisbane | Principal Investigator |
| Stephen Windley | Doctors@Carindale | Principal Investigator |
| Luke Katahanas | Capalaba Medical Centre | Principal Investigator |
| Bernardine McKellar | Red Hill Doctors Surgery | Principal Investigator |
| Evan Jones | University of Sunshine Coast Clinical Trials Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Red Hill Doctors Surgery | Brisbane | Queensland | 4059 | Australia | ||
| Mater Hospital - Brisbane |
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| eLab Flu Test | Device | The eLab Flu 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 nasopharyngeal swab samples. The eLab Flu Test generates a result within 10 minutes. |
|
| Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) | Device | 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. |
|
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits. |
| Day 1 |
| Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza B by Respirio Flu Test. | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits. | Day 1 |
| Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza B by eLab Flu Test. | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits. | Day 1 |
| Percent of participants who correctly interpret result of Respirio Flu Test. | Agreement between trained staff and participants. Report as a percentage of participants with 95% confidence limits. | Day 1 |
| Scores from questionnaire to assess ease of use, comfort and convenience of Respirio 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). | Day 1 |
| Brisbane |
| Queensland |
| 4101 |
| Australia |
| Doctors@Carindale | Brisbane | Queensland | 4152 | Australia |
| Capalaba Medical Centre | Redland | Queensland | 4157 | Australia |
| Clinical Trials Centre - University of the Sunshine Coast | Sippy Downs | Queensland | 4556 | Australia |
| Barwon Health - Geelong | Geelong | Victoria | 3220 | Australia |
| The Royal Children's Hospital | Melbourne | Victoria | 3052 | Australia |
| ID | Term |
|---|---|
| D020133 | Reverse Transcriptase Polymerase Chain Reaction |
| ID | Term |
|---|---|
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
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