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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05897515




Registration number
NCT05897515
Ethics application status
Date submitted
7/06/2023
Date registered
9/06/2023
Date last updated
30/04/2024

Titles & IDs
Public title
LIAISON NES Influenza (FLU) A/B & Coronavirus Disease 2019 (COVID-19) Clinical Agreement in Australia
Scientific title
LIAISON NES Flu A/B & COVID-19 Clinical Agreement in Australia
Secondary ID [1] 0 0
DSM-PROT-005131
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza A 0 0
Influenza Type B 0 0
Coronavirus Disease 2019 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - LIAISON NES FLU A/B & COVID-19

Other: Blinded, Prospective Arm - Clinical specimens shall be collected prospectively from patients with signs or symptoms of respiratory tract infection. Nasal swab in Copan universal transport media (UTM) 3 milliliters for comparator testing should be collected by a healthcare professional.
Where subjects are willing and able, up to 40% of nasal swab for the investigational device will be self-collected under the guidance and supervision of a healthcare professional.
Nasopharyngeal (NPS) specimens (optional) should only be collected by a healthcare professional. All specimens collected from children 13 years or younger should only be collected by a trained healthcare professional. Follow the Centers for Disease Control and Prevention guidelines for collecting NPS swabs, unless otherwise specified by the sponsor.


Diagnosis / Prognosis: LIAISON NES FLU A/B & COVID-19
The LIAISON® NES FLU A/B & COVID-19 assay used on the LIAISON® NES instrument is a real-time PCR system that enables the direct amplification, detection and differentiation of Flu A viral RNA, Flu B viral RNA and SARS-CoV-2 RNA from dry nasal swabs. Nasal Swabs can be professionally collected by a Healthcare Provider or self-collected by the patient under the supervision of the healthcare provider. The collected nasal swab can then be directly loaded into the cartridge without nucleic acid extraction.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Diagnostic accuracy
Timepoint [1] 0 0
Samples will be tested on LIAISON NES within one hour of collection.

Eligibility
Key inclusion criteria
- Human patients with active signs and symptoms of respiratory tract infection at time
of collection

- Specimens collected within 7 days of symptom onset for the initial collection

- Availability of age, gender, race, ethnicity, collection dates, collection time,
routine respiratory testing method, routine respiratory result, signs and symptoms
(e.g., fever), date of symptom onset for each symptom, vaccination status (Flu and
COVID-19, as applicable), pre-existing medical conditions (as applicable), medications
(e.g., COVID-19 antivirals), etc. for each subject
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Incorrect swab type

- Incorrect transport media

- Incorrect specimen handling (specimens not stored at recommended temperature)

- Samples collected >7 days from symptom onset

- Subjects not consented

Study design
Purpose of the study
Diagnosis
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/10/2023
Sample size
Target
Accrual to date
Final
233
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Grampians Health - Ballarat
Recruitment postcode(s) [1] 0 0
3350 - Ballarat

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
DiaSorin Molecular LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The DiaSorin Molecular LIAISON® NES FLU A/B & COVID-19 real-time polymerase chain reaction
(RT-PCR) assay is intended for use on the DiaSorin LIAISON® NES instrument for the in-vitro
qualitative detection and differentiation of nucleic acid from influenza A, influenza B and
SARS-CoV-2 virus from dry nasal swabs (NS) from human patients with signs and symptoms during
the acute phase of respiratory tract infection in conjunction with clinical and
epidemiological risk factors.

The LIAISON® NES FLU A/B & COVID-19 assay is intended for use as an aid in the differential
diagnosis of influenza A, influenza B and SARS-CoV-2 infection in a professional laboratory
setting.

Negative results do not preclude influenza A, influenza B, or SARS-CoV-2, infection and
should not be used as the sole basis for patient management decisions. The assay is not
intended to detect the presence of the influenza C virus.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05897515
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janet Farhang, PhD
Address 0 0
DiaSorin Molecular/Luminex Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries