None listed
Conditions
Brief summary
Toshiba medical systems have developed a new rapid diagnostic test device kit for influenza using new technology from current rapid tests available. The device is able to detect influenza virus in a much smaller sample and provide a result in around ten minutes. It will be compared with the Denka Seiken QuickNavi POCT device already marketed for use overseas for accuracy of results however neither device will be used to make a diagnosis. The diagnosis will be made from the accepted RT-PCR (separation culture) test. Participants will have 3 samples taken from either the nose or throat. 1sample for the culture and 1 sample for each device.
Interventions
Analysis of Toshiba's rapid diagnosis of nasal or throat swabs to detect Influenza virus A or B by new point of care testing (POCT) device using optical attenuation caused by reflection or scattering at formed immune complexes, the accuracy of results will be compared with an existing rapid influenza POCT device.
Diagnosis of influenza will only be made from the sample analysed by the Australian accepted standard RT-PCR test.
Participants will provide 3 samples in total at the one visit from ei
Analysis of Toshiba's rapid diagnosis of nasal or throat swabs to detect Influenza virus A or B by new point of care testing (POCT) device using optical attenuation caused by reflection or scattering at formed immune complexes, the accuracy of results will be compared with an existing rapid influenza POCT device. Diagnosis of influenza will only be made from the sample analysed by the Australian accepted standard RT-PCR test. Participants will provide 3 samples in total at the one visit from either nose or throat. One for each of the devices and one for the RT-PCR test Participants will be asked about the onset of their influenza symptoms and what those symptoms are and have their temperature taken.
Sponsors
South Australian Health & Medical Research Insitute
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Consenting adults or children (parent, guardian, or legal representative providing consent) presenting with influenza symptoms in whom there is a physician assessment of suspected influenza. Persons willing to participate and give consent
Exclusion criteria
lack of symptoms persons unable to provide all 3 samples (for any reason) Onset of symptoms greater than 7 days
Outcome results
None listed