Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test in detecting Influenza A, when used by subjects, as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).
The secondary aims are to:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Respirio Flu Test | Experimental | Upper respiratory tract samples from participants will be tested with:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respirio Flu Test | Device | The Respirio Flu Test is a rapid 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 ReverseTranscriptase 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 95% 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 95% 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 95% 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taringa 7 Day Medical Practice | Brisbane | Queensland | 4068 | Australia | ||
| Graceville Medical |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| Sofia® Influenza A+B Fluorescent Immunoassay (FIA) | Device | Sofia® Influenza A+B Fluorescent Immunoassay (FIA) employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash samples taken directly from symptomatic patients. |
|
Establish specificity against a gold standard. Report as a percentage of participants with 95% confidence limits. |
| Day 1 |
| Percent of participants positive for influenza A by Sofia® Influenza A+B Test and Respirio Flu Test. | Establish positive agreement against an imperfect standard. Report as a percentage of participants with 95% confidence limits. | Day 1 |
| Percent of participants negative for influenza B by Sofia® Influenza A+B Test and Respirio Flu Test. | Establish negative agreement against an imperfect standard. Report as a percentage of participants with 95% confidence limits. | Day 1 |
| Combine positive and negative agreement of Respirio Flu Test and Sofia® Influenza A+B Test to establish overall agreement. Report as a percentage of participants with 95% 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 the following: • Total number of responses to each question and the percentage of participants selecting each response (most on a 5 point Likert scale). | Day 1 |
| Percent of participants correctly determining eligibility and conditions for use of Respirio Flu Test from scores on a label comprehension questionnaire. | The label comprehension questionnaire will provide the following data
| Day 1 |
| Weight of sample deposited in Respirio Flu Test. | Establish minimum weight of sample required to obtain a valid result from the Respirio Flu Test. | Day 1 |
| Brisbane |
| Queensland |
| 4075 |
| Australia |
| Inala Primary Care | Brisbane | Queensland | 4077 | Australia |
| Limestone Medical Centre | Ipswich | Queensland | 4305 | 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 |
Not provided
Not provided