The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614001049662
Ethics application status
Approved
Date submitted
26/08/2014
Date registered
1/10/2014
Date last updated
26/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Diagnostic accuracy and reliability of the Toshiba rapid influenza diagnostic kit compared to the quickNavi diagnostic kit and polymerase chain reaction (PCR) test
Scientific title
In patients with flu symptoms, does the Toshiba rapid influenza diagnostic kit, compared to the Quick-navi diagnostic kit and PCR test give accurate & reliable diagnosis of influenza
Secondary ID [1] 285144 0
Nil known
Universal Trial Number (UTN)
U1111-1160-2816
Trial acronym
SMART ID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
influenza 292731 0
Condition category
Condition code
Inflammatory and Immune System 293026 293026 0 0
Other inflammatory or immune system disorders
Infection 293208 293208 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 289995 0
Early detection / Screening
Intervention code [2] 289996 0
Diagnosis / Prognosis
Comparator / control treatment
Influenza diagnosis made from RT-PCR test (separation culture) as a control
Quick Navi rapid influenza diagnosis kit as comparator
Control group
Active

Outcomes
Primary outcome [1] 292891 0
Diagnostic testing of nasal and throat sampling on Toshiba's scanning system compared to the QuickNavi existing rapid point of care test (POCT) device to determine the accuracy of Toshiba's POCT against and existing POCT.
Timepoint [1] 292891 0
ten minutes from sampling
Secondary outcome [1] 309879 0
Compare both POCT devices for accuracy of nasal and throat sampling results for influenza against the PCR test
Timepoint [1] 309879 0
in 72 hours from sampling

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
lack of symptoms
persons unable to provide all 3 samples (for any reason)
Onset of symptoms greater than 7 days

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects who present with influenza symptoms in the opinion of their doctor, will be asked to participate as will the parent or legal guardian of minors. They will be given a patient information sheet to read and time for their questions to be answered. Only if they willingly agree to participate will they be asked to sign a consent form. They will be randomly assigned to either 3 nasal or 3 throat swabs collection of nasal or throat discharge material for analysis of influenza A or B or negative results.
first swab will always be taken for the rt-PCR test as this is the accepted test for influenza diagnosis. Only this result will be used for the diagnosis and the patient will be notified of this result.
The second swab will be randomly assigned to the Toshiba POCT device or the Quick Navi POCT device used as a comparator in this trial. The third swab will be the reverse of the second swab, for example if the Quick Navi is randomised as swab 2 then the Toshiba POCT device will be used for testing swab 3.
computerised sequence generation used to generate randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Physician or trial nurse will open sealed packet which will indicate Nasal or throat swab to be taken. In this study patient samples will be further randomised in a 1:1 fashion to either the Toshiba device or to the quicknavi device per the order in which the devices are to be used to analyse swabs 2 and 3
Swab 1 will always be for rt-PCR be it nasal or throat swab
Swab 2 could be for Toshiba POCT or Quick Navi
Swab 3 would be reverse order of swab 2
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
In each type of sample, testing results obtained by product under investigation will be compared to that of the control product. Sensitivity, specificity and the overall concordance rate will be calculated. If the result of the product under investigation does not match the control device results the result will be compared with the rt-pct results. If these results match the investigative product will be considered as valid
For device approval in Japan, a new reagent test kit should achieve more than 90% correlativity between the new test kit and existing test kite/established methods the study is powered to test this requirement.
The Japanese Authority (Pharmaceuticals and Medical Device Agency) requests a clinical trial which tests more than minimum sample size (50 people) for each target and achieves more than 90% accordance rate in comparing with the incumbents for each target all venders which want to enter the Influenza test kit market. To test more than 50 positives (each A and B), we suppose that we need to recruit around 1.5 to 2.0 times of minimum number of participants

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 8574 0
5000 - Adelaide
Recruitment postcode(s) [2] 8538 0
5000 - City West Campus

Funding & Sponsors
Funding source category [1] 289772 0
Commercial sector/Industry
Name [1] 289772 0
Toshiba Medical systems corporation
Address [1] 289772 0
1385 Shimoishigami, OtawarsTochigi Prefecture, 324-8550 Japan
Country [1] 289772 0
Japan
Primary sponsor type
Other
Name
South Australian Health & Medical Research Insitute
Address
North Terrace Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 288461 0
None
Name [1] 288461 0
Address [1] 288461 0
Country [1] 288461 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291520 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 291520 0
129 Glen Osmond Rd Eastwood Adelaide South Australia 5063
Ethics committee country [1] 291520 0
Australia
Date submitted for ethics approval [1] 291520 0
21/08/2014
Approval date [1] 291520 0
06/10/2014
Ethics approval number [1] 291520 0
IRB00005845

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50614 0
Prof Steven Wesselingh
Address 50614 0
South Australian Health and Medical Research Institute (SAHMRI)
North Terrace Adelaide SA 5000
Country 50614 0
Australia
Phone 50614 0
+61 8 81284000
Fax 50614 0
Email 50614 0
steve.wesseling@sahmri.com
Contact person for public queries
Name 50615 0
Ms Nadine Smith
Address 50615 0
South Australian Health and Medical Research Institute (SAHMRI)
North Terrace Adelaide SA 5000
Country 50615 0
Australia
Phone 50615 0
+61 8 81284000
Fax 50615 0
Email 50615 0
nadine.smith@sahmri.com
Contact person for scientific queries
Name 50616 0
Prof Steven Wesselingh
Address 50616 0
South Australian Health and Medical Research Institute (SAHMRI)
North Terrace Adelaide SA 5000
Country 50616 0
Australia
Phone 50616 0
+61 8 81284000
Fax 50616 0
Email 50616 0
steve.wesselingh@sahmri.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary